Intraoperatorive hydroxyethyl starch: A safe therapy or a poison? | Revista Española de Anestesiología y Reanimación

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"tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "588" "paginaFinal" => "593" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "R. Uña Orejón, I. del Huercio Martinez, C. Casinello Ogea, M. del Prado Ureta Tolsada, S. Uña Orejon" "autores" => array:5 [ 0 => array:4 [ "nombre" => "R." "apellidos" => "Uña Orejón" "email" => array:2 [ 0 => "Gorote90@gmail.com" 1 => "runa.hulp@salud.madrid.org" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "I." "apellidos" => "del Huercio Martinez" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "b" "identificador" => "aff0010" ] ] ] 2 => array:3 [ "nombre" => "C." "apellidos" => "Casinello Ogea" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "c" "identificador" => "aff0015" ] ] ] 3 => array:3 [ "nombre" => "M." 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"apellidos" => "Uña Orejon" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "e" "identificador" => "aff0025" ] ] ] ] "afiliaciones" => array:5 [ 0 => array:3 [ "entidad" => "Jefe de Sección Bloque Quirúrgico, Servicio de Anestesiología, Hospital “La Paz”, Madrid, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Médico Residente, Servicio de Anestesiología, Hospital “La Paz”, Madrid, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "FEA Servicio de Anestesiología, Hospital “Miguel Servet”, Zaragoza, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "FEA Servicio de Anestesiología, Hospital “La Paz”, Madrid, Spain" "etiqueta" => "d" "identificador" => "aff0020" ] 4 => array:3 [ "entidad" => "FEA Servicio de Anestesiología, Hospital General de Albacete, Spain" "etiqueta" => "e" "identificador" => "aff0025" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Almidones intraoperatorios: ¿medicamentos o venenos?" ] ] "textoCompleto" => "IntroductionThe old debate about “crystalloids versus colloids” seemed to be settled after the excellent review by Chappell et al.<a class="elsevierStyleCrossRef" href="#bib0240">1</a> (2008). However recent clinical trials have rekindled the controversy again.In a clinical trial with 798 septic patients, Perner et al.<a class="elsevierStyleCrossRef" href="#bib0245">2</a> could conclude that that the use of potato-derived hydroxyethyl starch (HES 130/0.42) was associated with a higher incidence of renal failure, a higher need for renal replacement therapy (RRT) and increased mortality rate. The trial conducted by Myburgh et al.<a class="elsevierStyleCrossRef" href="#bib0250">3</a> (CHEST) which included 7000 patients with septic shock who had been admitted to the ICU (1937 were septic patients, 2940 were post-surgical patients) was conducted in this study with the administration of corn-derived HES 130/0.4. No increased mortality rates were found, however, an increased need for renal replacement therapy (RRT) and higher incidence of renal failure were found. These studies could justify the last published “Surviving Sepsis Campaign” guides where the initial resuscitation (first 6h) is recommended to be initiated using only crystalloids (Dellinger et al.<a class="elsevierStyleCrossRef" href="#bib0255">4</a> 2013).In June 2013, the PRAC (Pharmacovigilance Risk Assessment Committee) of the European Medicines Agency (EMA) concluded that these solutions<a class="elsevierStyleCrossRef" href="#bib0260">5</a> should no longer be used. However, in October 2013 and after evaluating other studies with polytraumatized patients (Guidet<a class="elsevierStyleCrossRef" href="#bib0265">6</a>), septic patients (James<a class="elsevierStyleCrossRef" href="#bib0270">7</a>) and mainly patients presenting septic shock (Annane et al.<a class="elsevierStyleCrossRef" href="#bib0275">8</a>), the FDA and the European Medicines Agency (EMA) endorsed new recommendations for the authorization of HES to treat hypovolemia caused by acute blood loss, where treatment with crystalloids alone are not considered to be sufficient. However starches should be avoided in septic patients and limit their use for a period no longer than 24h, with continuous renal function vigilance within the first 90 days.Nevertheless, due to an imitational effect after the EMA-FDA recommendations, these drugs/fluids have been avoided in many scenarios, including surgical and polytraumatized patients even with massive blood loss, who have little in common with the patients with global increased permeability syndrome (GIPS) that the septic patient presents.The aim of this article is to evaluate if there is enough current evidence to use the HES in surgical patients.The objectives of fluid therapy: which fluid should we administer?The intravenous fluid therapy could be considered as one of the most remarkable and often treatments administered by the anaesthesiologists, surgeons.The type of solution will depend on the compartment we would like to replace. Interstitial fluid hydration and electrolyte replacement should be carried out using isotonic-balanced electrolyte crystalloids.<a class="elsevierStyleCrossRefs" href="#bib0280">9,10</a> To do so, insensible loss of fluid caused by surgical exposure of tissue should be evaluated (0.5–1ml/kg/h) together with urine output.<a class="elsevierStyleCrossRef" href="#bib0290">11</a> Preoperative fasting does not need any replacement therapy and the classical-known third spacing (not the anatomical space) does not really exists.<a class="elsevierStyleCrossRefs" href="#bib0295">12,13</a>Patients under a surgical procedure show a reduced effective circulating volume, which means intravascular loss of fluid, hypovolemia and hypoperfusion. In these cases, vascular replacement of fluid would increase preload, keep the systolic volume, cardiac output, tissue perfusion, and oxygen delivery, thus avoiding organ failure.<a class="elsevierStyleCrossRef" href="#bib0310">15</a> If this replacement is carried out using crystalloids exclusively, it can be necessary to administer larger volumes of fluid, causing a secondary dilution of plasma proteins, thus decreasing oncotic pressure and a shift of the administered fluid into the interstitium. On the other hand, colloids can expand the effective circulating volume (1:1, 3) using less volume,<a class="elsevierStyleCrossRef" href="#bib0240">1</a> and it has also been demonstrated to keep their effect longer in time causing less production of oedema. Moreover, starches exert a protective effect on the glycocalix due to their anti-inflammatory properties.<a class="elsevierStyleCrossRef" href="#bib0315">16</a>The election of the type of fluid should depend on the physiopathology of the patient. Colloids are indicated to maintain the effective circulating volume in the acute haemorrhage state and are not indicated for hydration therapy. If global permeability is increased as well as distributive shock, fluid therapy should be conducted using crystalloids as pointed out before. However, in the case of acute blood loss without presenting increased vascular permeability with hypovolemic shock, fluid therapy should be based on the combination of crystalloids together with colloids and hemoderivatives. Patients with higher capillary hydrostatic pressure would benefit better with colloids than those with lower capillary pressures.How much fluid should we administer?Preload is the end diastolic volume that stretches the left or the right ventricles of the heart to its greatest dimensions. According to the Frank–Starling law of the heart, stroke volume increases to an increase in the end diastolic volume up to a maximum point from which an increase of blood filling does not increase stroke volume and can even increase hypervolemia and tissue hypoxia.<a class="elsevierStyleCrossRefs" href="#bib0310">15,17</a>This optimum length of the cardiac muscle that increases stroke volume to its maximum can be identified by different means:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005">(a)Static preload parameters: Central Venous Pressure (CVP) and Pulmonary Capillary Pressure (PCP), although they cannot predict fluid responsiveness and do not reflect the intravascular volume state.<a class="elsevierStyleCrossRef" href="#bib0325">18</a> Cardiac output was considered a few years ago as the “gold standard” of static parameters but, as we will explain later, it can also continuously measured.</li><li class="elsevierStyleListItem" id="lsti0010">(b)Minimally invasive cardiac output monitoring and preload dynamic responsiveness: these monitors can continuously assess cardiac output and predict its responsiveness to a load of fluid. There are based on the analysis of arterial pulse wave that are related to stroke volume variation (SVV), pulse pressure variation (PPV) and pleth variability index (PVI).<a class="elsevierStyleCrossRefs" href="#bib0305">14,19–21</a> These monitors are indicated for patients with normal synus rhythm under mechanical ventilation (volume-controlled ventilation with, at least 8ml/kg with closed thorax), under no presence of hypertension or cardiac failure. It is likely to obtain erroneous measurements if high PEEP and/or abdominal pressures are present.</li><li class="elsevierStyleListItem" id="lsti0015">(c)Passive leg raising test: this manoeuvre increases preload and is useful to predict if the patient can respond to a load of fluid with an increase in cardiac output.<a class="elsevierStyleCrossRef" href="#bib0345">22</a> It can also be performed for patients under the limited conditions stated before.</li><li class="elsevierStyleListItem" id="lsti0020">(d)Objective monitoring: microcirculation parameters and tissue oxygen concentration<a class="elsevierStyleCrossRefs" href="#bib0350">23–25</a>: this monitoring can assess perfusion and oxygen tissue concentration. Lactate levels and mixed venous oxygen saturation (SvO2) are influenced by oxygen delivery and tissue oxygen uptake, and can quickly give information about an initial anaerobic metabolism. Central venous-arterial PCO2 difference can also indicate the ability of the cardiovascular system to eliminate CO2 produced by peripheral tissues and can be inversely related to cardiac output. Furthermore, if central venous-arterial PCO2 difference is higher than 6mmHg, a peripheral hypoperfusion can be high even if values of central oxygen saturation is within the normal range.</li></ul>Intraoperative and postoperative use of colloidsVan Der Linden et al.<a class="elsevierStyleCrossRef" href="#bib0365">26</a> evaluated the collateral effects of corn-derived HES 130/0.4 or potato-derived HES120/0.42 compared to other fluids (gelatine, albumin and crystalloids). They included in their meta-analysis 59 randomly assigned studies and 4529 patients who had previous major cardiac and non-cardiac surgery, trauma or burn patients. They concluded that the use of HES 130/0.4 or 130/0.42 in these patients did not increase the risk for renal failure (urine output, serum creatinine, or renal replacement therapy), haemorrhage, or mortality. Patients who received HES 130/0.4 had less number of blood transfusions.Van der Linden et al.<a class="elsevierStyleCrossRef" href="#bib0370">27</a> carried out a retrospective study with 1495 children that had cardiac surgery with extracorporeal circulation. They compared patients who received crystalloids together with HES 130/0.4 (exclusively derived from corn) with albumin during their hospital stay. The study concluded that weight gain, bleeding and transfusion needs were less frequent in children who received HES 130/0.4 compared to those who received albumin alone. No differences in postoperative serum creatinine, therapy needs, morbidity and mortality, were found.The meta-analysis conducted by Martin et al.<a class="elsevierStyleCrossRef" href="#bib0375">28</a> studied the impact on renal morbidity after the administration of crystalloids together with HES 130/0.4 (only HES derived from corn), compared to another alternative in the postoperative period in different scheduled surgeries. They analyzed 17 randomly assigned studies that included 1230 patients. In this study it was confirmed that the HES 130/0.4 had no association with any increase in serum creatinine, any decrease in renal clearance or the need for renal replacement therapy (RRT). This meta-analysis only compared HES 130/0.4 derived from corn. However, it included studies with less tan 150 patients and a follow-up ≤24h in the third part of the studies.The systematic review of Gillies et al.<a class="elsevierStyleCrossRef" href="#bib0380">29</a> compared the effect of HES 130/0.4 or HES 130/0.42 to an another alternative, in terms of mortality and renal morbidity (development of renal failure and the need for RRT), in the postoperative period after cardiac and non-cardiac surgery. They included 1567 patients from 19 randomly selected studies. They did not find any increase in mortality, renal failure, or RTT in the HES 130/0.4 group. Nevertheless, the authors did not find any benefits and concluded that there were not enough data to suggest the HES 130/0.4 as a routine therapy for surgical patients.The Wilkes and Navickis<a class="elsevierStyleCrossRef" href="#bib0385">30</a> meta-analysis included 15 randomly selected studies that investigated the need for RRT after major cardiac and non-cardiac surgery where other alternatives (except haemoglobin substitutes) were compared to HES. 4409 patients were included of whom 2872 belonged to CHEST study (65%), and in 362 patients high molecular weight HES were administered. Eighty-three from a total of 2157 patients (3.8%) needed RRT while in 56 cases from a total of 2252 (2.5%) from control group needed RRT. A higher need for RRT was observed in the HES group compared to crystalloids and concluded that after treating 85 patients with HES one patients would need RRT compared to those treated with crystalloids. However, this conclusion can be explained by the use of HES 200/0.62 and 450/0.7 which can accumulate and originate more incidence of renal failure than HES 130/0.4.The He et al.<a class="elsevierStyleCrossRef" href="#bib0390">31</a> study, evaluated the incidence of mortality in the ICU patients without sepsis, using HES 6% compared to other alternatives such as gelatines (31%), gelatines plus lactate (9%) albumin (13.6%), albumin plus lactate (4.5%), gelatines plus albumin and lactate (4.5%) lactate (9%), saline (13.6%), fresh frozen plasma (4.5%) and a non-specific crystalloid (9%). 22 randomly assigned studies were included (6064 patients, of whom 3704 were surgical patients and 1016 were not). 4720 of those patients belonged to the CHEST study (who were selected because of the absence of sepsis, although the surgical criteria was not taken into account). This meta-analysis concluded that patients who were resuscitated using HES received less total fluid volume, and presented better haemodynamic stability and had less weight gains without differences in mortality, the need for RRT, haemorrhage or transfusion compared to other alternatives. However, most of these studies had less than 150 patients, except for the CHEST study, and 426 patients received high molecular weight HES.The multicentre randomized study of Brandstrup et al.<a class="elsevierStyleCrossRef" href="#bib0395">32</a> studied the morbidity and mortality of 172 patients who had previous colorectal surgery, comparing crystalloids plus HES 6%, in a restrictive regimen trying to keep a hydric balance close to zero, to a non-restrictive regimen based on crystalloids where HES 6% was only administered when the bleeding reached 500ml. In the group that received the restrictive regimen with HES 6% a significant less number of cardiopulmonary complications was observed compared to the non-restrictive group. Patients in this last group suffered an increase in total body weight between 3 and 7kg.The Moretti et al.,<a class="elsevierStyleCrossRef" href="#bib0400">33</a> Mythen<a class="elsevierStyleCrossRef" href="#bib0405">34</a> and Yates et al.<a class="elsevierStyleCrossRef" href="#bib0410">35</a> randomized studies in patients after major non-cardiac elective surgery, demonstrated that the intraoperative administration of crystalloids alone, was associated with a higher total volume infusion, with more presence of postoperative oedema, more weight gains, more intestinal dysfunction (postoperative nausea and vomiting) and with more cardiopulmonary related complications compared to HES 130/0.4 and crystalloid combination.Zeng et al.<a class="elsevierStyleCrossRef" href="#bib0415">36</a> analyzed the impact of early goal-directed therapies in 60 hypertensive elderly patients who had gastrointestinal surgery. Bolus of 200ml of HES 130/0.476% were administered when systolic volume variations were <13%, and inotrope agents were administered if no response was observed. No differences were found in cardiac complications. However, the intraoperative administration of crystalloids together with boluses of HES 130/0.4 and the use of inotropes, was associated with a greater haemodynamic stability, a slower rate of volume infusion, less postoperative oedema, less intestinal dysfunction, and shorter hospital stay compared to the classic crystalloid strategy.The randomized double-blind study of Kancir et al.<a class="elsevierStyleCrossRef" href="#bib0420">37</a> was performed in 40 patients who had previous radical prostatectomy. HES 130/0.4 6% vs. saline 0.9%; (7.5ml/kg) was administered during the first hour of surgery, followed by HES vs. saline for the next hours with a dose of 5ml/kg. They concluded that the use of HES 130/0.4 compared to saline did not cause any impairment in the biochemical parameters for renal failure. However, patients treated with HES showed a greater mean arterial pressure and patients treated with saline alone showed significant lower levels of vasopressin and aldosterone.Kimberger et al.<a class="elsevierStyleCrossRef" href="#bib0425">38</a> studied the impact of different strategies of goal-directed therapy on intestinal microvasculature in an animal model that had laparoscopic colon resection. They could conclude that when central venous saturation was lower than 60%, a Ringer lactate plus HES 130/0.4 6% infusion could considerably increase tissues oxygen content and perfusion in the peri-anastomotic microcirculation, compared to a single bolus of ringer lactate or no fluid administration.Cui et al.<a class="elsevierStyleCrossRef" href="#bib0430">39</a> analyzed the impact of replacing blood loss with HES 6% with a 1 to 1 proportion with two types of HES: 130/0.4 vs. 200/0.5. Thirty patients scheduled for hepatic surgery with a significant haemorrhage were studied. Intestinal microcirculation and clinical parameters were analyzed. They demonstrated that HES 130/0.4 6% could increase tissue perfusion and oxygen content in the intestinal microvasculature and decrease the time for the first bowel sound to appear and hospital stay, compared to HES 200/0.5.Regarding patients who had kidney transplant, Legendre et al.<a class="elsevierStyleCrossRef" href="#bib0435">40</a> found anatomical lesions due to a tubular starch accumulation ‘nephrosis-like’ in 80% of the kidneys from patients after brain death who had received HES 200/0.65.The Cittanova et al.<a class="elsevierStyleCrossRef" href="#bib0440">41</a> and Blasco et al.<a class="elsevierStyleCrossRef" href="#bib0445">42</a> studies compared the complications of patients with previous kidney transplant from patients who suffered brain death that had been administered HEA 130/0.4 and HEA 200/0.65 before. They found that patients who had kidney transplant from donors who had received HEA 130/0.65 or 0.42 had lower levels of serum creatinine and better renal function for a year after the transplant compared to the administration of HEA 200/0.65.One prospective study<a class="elsevierStyleCrossRef" href="#bib0450">43</a> included patients who had a previous kidney transplant and evaluated the impact that the treatment with HES caused on the donors who suffered brain death. 986 patients were included (529 from donors with brain death) and 42% of those who had kidney transplant received HES. The use of HES, the age, the warm ischaemia time, and previous creatinine in the donors was found an independent factor for the need of dialysis during the first post-transplant week.In conclusion, all these studies suggest that in surgical patients presenting haemorrhage, the attempt to replace the loss of fluid from the intravascular compartment using crystalloids exclusively, is associated with more interstitial oedema, more weight gains and a worse oxygen utilization by the tissues.<a class="elsevierStyleCrossRefs" href="#bib0400">33–36</a> In abdominal surgery this can also increase bowel transit time thus increasing the risk for wound dehiscence.Furthermore, these studies verify the safety of HES 130/0.4 when it is correctly administered using the lowest effective dose (no more than 30ml/kg and no longer than 24h). They should also not be administered when the patient suffers from renal failure, or cardiac, liver failure, coagulopathy or intracranial haemorrhage. If the adequate dose is administered and no haemodynamic stability is reached, vasopressors may be a useful alternative. So in the surgical context (except for brain-dead kidney donors) HES 130/0.4 6% does not produce more incidence of renal failure, need for renal replacement therapy,<a class="elsevierStyleCrossRefs" href="#bib0365">26–29,44</a> coagulopathy<a class="elsevierStyleCrossRefs" href="#bib0365">26,29,44</a> or more incidence of mortality<a class="elsevierStyleCrossRefs" href="#bib0365">26,29,44</a> when HES 130/0.4–0.42/6% are administered together with saline compared to unbalanced crystalloids.This could encouraged the European Medicines Agency to keep the indication of HES 130/0.4–0.42 for important bleeding, so practitioners could be more inclined to choose this starch based on the benefits and its safety despite its high cost.<a class="elsevierStyleCrossRef" href="#bib0460">45</a>Use of HES 130/0.4 with a balanced solution vs. balanced crystalloid in the postoperative periodFeldheiser et al.<a class="elsevierStyleCrossRef" href="#bib0465">46</a> conducted a randomized double-blind trial in 50 patients with ovarian cancer where a goal-directed therapy was used based on a Doppler ultrasound technique during surgery time. Patients were administered balanced crystalloids or HES 13070.4/6% in a balanced solution. They concluded that the intraoperative administration of HES 130/0.4/6% alone in a balanced solution together with the use of inotropes in a goal-directed therapy is associated with a more stable haemodynamic profile, lower total volume fluid administration, less plasma needs, and less postoperative oedema compared to a goal-directed therapy using crystalloids alone. Furthermore, no renal failure incidence was observed and no mortality rate increased. The number of blood transfusions was lower using HES 130/0.4 compared to a crystalloids regimen.Krebbel et al.<a class="elsevierStyleCrossRef" href="#bib0470">47</a> conducted a randomized double-blind study in 40 patients who were scheduled for total hip arthroplasty under general anaesthesia and using a goal-directed therapy based on Doppler ultrasound. The algorithm was conducted following systolic volume; once it was decreased a bolus of fluid was administered every 5min as long as the systolic volume increased 10%. Vasopressors and inotrope agents to keep arterial mean pressure in each group were used. Patients were randomly assigned to one group where boluses of 200ml of saline 0.9% were used compared to the other group where boluses of 200ml of HES 130/0.42/6% with a balanced solution were administered. The study revealed that patients receiving saline presented more acidosis after surgery and a base excess more negative compared to patients who received balanced crystalloids and HES 130/0.42 (base excess: −2.0mmol/l (−3.1 to −1.1) versus base excess: −0.4mmol/l (−1.2 to 0.7), respectively). According to Stewart equations, the most negative value of the base excess in the saline group was due to an excess of chloride ion, while no differences in lactate and albumin levels were found. Furthermore, the intraoperative administration of HES 130/0.42/6% in a balanced solution together with inotrope agents under a goal-directed therapy was associated with a better haemodynamic stability, less fluid volume administration and less plasma administration along with less postoperative oedema compared to the goal-directed therapy group with crystalloids. No renal impairment or more transfusion were observed with HES 130/0.42 compared to a saline solution alone.In summary, HES 130/0.4/6% administered together with a balanced solution and balanced crystalloids could prevent hyperchloremic acidosis and its deleterious consequences in the surgical context.ConclusionsAccording to the conflicting results from the current published studies, it is difficult to establish strong recommendations based on a good level of evidence, so more publications are needed to determine the exact role of starches in the surgical patient. Regarding the topic analyzed, there a few on-going studies, as the FLASH STUDY (ClinicalTrials.gov. <a id="intr0005" class="elsevierStyleInterRef" href="https://clinicaltrials.gov/NCT02502773">NCT02502773</a>) which compares the impact of postoperative complications related to HES 130/04 administration vs. saline in a goal-directed therapy protocol for abdominal surgery. Other studies that are evaluating renal function when starches are used for patients in orthopaedic surgery (<a id="intr0010" class="elsevierStyleInterRef" href="https://clinicaltrials.gov/NCT02361736">NCT02361736</a>), prostatectomy (VORA <a id="intr0015" class="elsevierStyleInterRef" href="https://clinicaltrials.gov/NCT01486563">NCT01486563</a>) and laparoscopic nephrectomy (VONE <a id="intr0020" class="elsevierStyleInterRef" href="https://clinicaltrials.gov/NCT01486550">NCT01486550</a>) are also being performed.However, HES 130/0.4 has shown better results when compared to crystalloids in surgical or traumatic haemorrhage, hypovolemic patients and tissue hypoperfusion syndrome since HES 130/0.4 can keep adequate tissue oxygen levels and efficient tissue perfusion, using lower volumes of fluid.Nonetheless, the PRAC recommendations should be followed in order to avoid secondary effects, and starches should be used exclusively in hypovolemia caused by acute haemorrhage, with the minimum effective dose and with a maximum dose of 30ml/kg for a period no longer than 24h following strict renal function vigilance for, at least, 90 day.Conflict of interestsRafael Uña Orejón has occasionally received honoraria from Baxter, Fresenius and Braum by lecturing in different forums.The other authors declare no conflict of interest." 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Special article

Intraoperatorive hydroxyethyl starch: A safe therapy or a poison?

Almidones intraoperatorios: ¿medicamentos o venenos?

R. Uña Orejóna,

Corresponding author

Gorote90@gmail.com
runa.hulp@salud.madrid.org

Corresponding author.

, I. del Huercio Martinezb, C. Casinello Ogeac, M. del Prado Ureta Tolsadad, S. Uña Orejone

a Jefe de Sección Bloque Quirúrgico, Servicio de Anestesiología, Hospital “La Paz”, Madrid, Spain

b Médico Residente, Servicio de Anestesiología, Hospital “La Paz”, Madrid, Spain

c FEA Servicio de Anestesiología, Hospital “Miguel Servet”, Zaragoza, Spain

d FEA Servicio de Anestesiología, Hospital “La Paz”, Madrid, Spain

e FEA Servicio de Anestesiología, Hospital General de Albacete, Spain

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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">The old debate about &#8220;<span class="elsevierStyleItalic">crystalloids versus colloids</span>&#8221; seemed to be settled after the excellent review by Chappell et al&#46;<a class="elsevierStyleCrossRef" href="#bib0240"><span class="elsevierStyleSup">1</span></a> &#40;2008&#41;&#46; However recent clinical trials have rekindled the controversy again&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">In a clinical trial with 798 septic patients&#44; Perner et al&#46;<a class="elsevierStyleCrossRef" href="#bib0245"><span class="elsevierStyleSup">2</span></a> could conclude that that the use of potato-derived hydroxyethyl starch &#40;HES 130&#47;0&#46;42&#41; was associated with a higher incidence of renal failure&#44; a higher need for renal replacement therapy &#40;RRT&#41; and increased mortality rate&#46; The trial conducted by Myburgh et al&#46;<a class="elsevierStyleCrossRef" href="#bib0250"><span class="elsevierStyleSup">3</span></a> &#40;CHEST&#41; which included 7000 patients with septic shock who had been admitted to the ICU &#40;1937 were septic patients&#44; 2940 were post-surgical patients&#41; was conducted in this study with the administration of corn-derived HES 130&#47;0&#46;4&#46; No increased mortality rates were found&#44; however&#44; an increased need for renal replacement therapy &#40;RRT&#41; and higher incidence of renal failure were found&#46; These studies could justify the last published &#8220;Surviving Sepsis Campaign&#8221; guides where the initial resuscitation &#40;first 6<span class="elsevierStyleHsp" style=""></span>h&#41; is recommended to be initiated using only crystalloids &#40;Dellinger et al&#46;<a class="elsevierStyleCrossRef" href="#bib0255"><span class="elsevierStyleSup">4</span></a> 2013&#41;&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">In June 2013&#44; the PRAC &#40;Pharmacovigilance Risk Assessment Committee&#41; of the European Medicines Agency &#40;EMA&#41; concluded that these solutions<a class="elsevierStyleCrossRef" href="#bib0260"><span class="elsevierStyleSup">5</span></a> should no longer be used&#46; However&#44; in October 2013 and after evaluating other studies with polytraumatized patients &#40;Guidet<a class="elsevierStyleCrossRef" href="#bib0265"><span class="elsevierStyleSup">6</span></a>&#41;&#44; septic patients &#40;James<a class="elsevierStyleCrossRef" href="#bib0270"><span class="elsevierStyleSup">7</span></a>&#41; and mainly patients presenting septic shock &#40;Annane et al&#46;<a class="elsevierStyleCrossRef" href="#bib0275"><span class="elsevierStyleSup">8</span></a>&#41;&#44; the FDA and the European Medicines Agency &#40;EMA&#41; endorsed new recommendations for the authorization of HES to treat hypovolemia caused by acute blood loss&#44; where treatment with crystalloids alone are not considered to be sufficient&#46; However starches should be avoided in septic patients and limit their use for a period no longer than 24<span class="elsevierStyleHsp" style=""></span>h&#44; with continuous renal function vigilance within the first 90 days&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">Nevertheless&#44; due to an imitational effect after the EMA-FDA recommendations&#44; these drugs&#47;fluids have been avoided in many scenarios&#44; including surgical and polytraumatized patients even with massive blood loss&#44; who have little in common with the patients with global increased permeability syndrome &#40;GIPS&#41; that the septic patient presents&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">The aim of this article is to evaluate if there is enough current evidence to use the HES in surgical patients&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">The objectives of fluid therapy&#58; which fluid should we administer&#63;</span><p id="par0030" class="elsevierStylePara elsevierViewall">The intravenous fluid therapy could be considered as one of the most remarkable and often treatments administered by the anaesthesiologists&#44; surgeons&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">The type of solution will depend on the compartment we would like to replace&#46; Interstitial fluid hydration and electrolyte replacement should be carried out using isotonic-balanced electrolyte crystalloids&#46;<a class="elsevierStyleCrossRefs" href="#bib0280"><span class="elsevierStyleSup">9&#44;10</span></a> To do so&#44; insensible loss of fluid caused by surgical exposure of tissue should be evaluated &#40;0&#46;5&#8211;1<span class="elsevierStyleHsp" style=""></span>ml&#47;kg&#47;h&#41; together with urine output&#46;<a class="elsevierStyleCrossRef" href="#bib0290"><span class="elsevierStyleSup">11</span></a> Preoperative fasting does not need any replacement therapy and the classical-known <span class="elsevierStyleItalic">third spacing</span> &#40;not the anatomical space&#41; does not really exists&#46;<a class="elsevierStyleCrossRefs" href="#bib0295"><span class="elsevierStyleSup">12&#44;13</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">Patients under a surgical procedure show a reduced effective circulating volume&#44; which means intravascular loss of fluid&#44; hypovolemia and hypoperfusion&#46; In these cases&#44; vascular replacement of fluid would increase preload&#44; keep the systolic volume&#44; cardiac output&#44; tissue perfusion&#44; and oxygen delivery&#44; thus avoiding organ failure&#46;<a class="elsevierStyleCrossRef" href="#bib0310"><span class="elsevierStyleSup">15</span></a> If this replacement is carried out using crystalloids exclusively&#44; it can be necessary to administer larger volumes of fluid&#44; causing a secondary dilution of plasma proteins&#44; thus decreasing oncotic pressure and a shift of the administered fluid into the interstitium&#46; On the other hand&#44; colloids can expand the effective circulating volume &#40;1&#58;1&#44; 3&#41; using less volume&#44;<a class="elsevierStyleCrossRef" href="#bib0240"><span class="elsevierStyleSup">1</span></a> and it has also been demonstrated to keep their effect longer in time causing less production of oedema&#46; Moreover&#44; starches exert a protective effect on the glycocalix due to their anti-inflammatory properties&#46;<a class="elsevierStyleCrossRef" href="#bib0315"><span class="elsevierStyleSup">16</span></a></p><p id="par0045" class="elsevierStylePara elsevierViewall">The election of the type of fluid should depend on the physiopathology of the patient&#46; Colloids are indicated to maintain the effective circulating volume in the acute haemorrhage state and are not indicated for hydration therapy&#46; If global permeability is increased as well as distributive shock&#44; fluid therapy should be conducted using crystalloids as pointed out before&#46; However&#44; in the case of acute blood loss without presenting increased vascular permeability with hypovolemic shock&#44; fluid therapy should be based on the combination of crystalloids together with colloids and hemoderivatives&#46; Patients with higher capillary hydrostatic pressure would benefit better with colloids than those with lower capillary pressures&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">How much fluid should we administer&#63;</span><p id="par0050" class="elsevierStylePara elsevierViewall">Preload is the end diastolic volume that stretches the left or the right ventricles of the heart to its greatest dimensions&#46; According to the Frank&#8211;Starling law of the heart&#44; stroke volume increases to an increase in the end diastolic volume up to a maximum point from which an increase of blood filling does not increase stroke volume and can even increase hypervolemia and tissue hypoxia&#46;<a class="elsevierStyleCrossRefs" href="#bib0310"><span class="elsevierStyleSup">15&#44;17</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">This optimum length of the cardiac muscle that increases stroke volume to its maximum can be identified by different means&#58;<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">&#40;a&#41;</span><p id="par0060" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Static preload parameters</span>&#58; Central Venous Pressure &#40;CVP&#41; and Pulmonary Capillary Pressure &#40;PCP&#41;&#44; although they cannot predict fluid responsiveness and do not reflect the intravascular volume state&#46;<a class="elsevierStyleCrossRef" href="#bib0325"><span class="elsevierStyleSup">18</span></a> Cardiac output was considered a few years ago as the &#8220;<span class="elsevierStyleItalic">gold standard&#8221;</span> of static parameters but&#44; as we will explain later&#44; it can also continuously measured&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">&#40;b&#41;</span><p id="par0065" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Minimally invasive cardiac output monitoring and preload dynamic responsiveness</span>&#58; these monitors can continuously assess cardiac output and predict its responsiveness to a load of fluid&#46; There are based on the analysis of arterial pulse wave that are related to stroke volume variation &#40;SVV&#41;&#44; pulse pressure variation &#40;PPV&#41; and pleth variability index &#40;PVI&#41;&#46;<a class="elsevierStyleCrossRefs" href="#bib0305"><span class="elsevierStyleSup">14&#44;19&#8211;21</span></a> These monitors are indicated for patients with normal synus rhythm under mechanical ventilation &#40;volume-controlled ventilation with&#44; at least 8<span class="elsevierStyleHsp" style=""></span>ml&#47;kg with closed thorax&#41;&#44; under no presence of hypertension or cardiac failure&#46; It is likely to obtain erroneous measurements if high PEEP and&#47;or abdominal pressures are present&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">&#40;c&#41;</span><p id="par0070" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Passive leg raising test</span>&#58; this manoeuvre increases preload and is useful to predict if the patient can respond to a load of fluid with an increase in cardiac output&#46;<a class="elsevierStyleCrossRef" href="#bib0345"><span class="elsevierStyleSup">22</span></a> It can also be performed for patients under the limited conditions stated before&#46;</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">&#40;d&#41;</span><p id="par0075" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Objective monitoring&#58; microcirculation parameters and tissue oxygen concentration</span><a class="elsevierStyleCrossRefs" href="#bib0350"><span class="elsevierStyleSup">23&#8211;25</span></a>&#58; this monitoring can assess perfusion and oxygen tissue concentration&#46; Lactate levels and mixed venous oxygen saturation &#40;SvO<span class="elsevierStyleInf">2</span>&#41; are influenced by oxygen delivery and tissue oxygen uptake&#44; and can quickly give information about an initial anaerobic metabolism&#46; Central venous-arterial PCO<span class="elsevierStyleInf">2</span> difference can also indicate the ability of the cardiovascular system to eliminate CO<span class="elsevierStyleInf">2</span> produced by peripheral tissues and can be inversely related to cardiac output&#46; Furthermore&#44; if central venous-arterial PCO<span class="elsevierStyleInf">2</span> difference is higher than 6<span class="elsevierStyleHsp" style=""></span>mmHg&#44; a peripheral hypoperfusion can be high even if values of central oxygen saturation is within the normal range&#46;</p></li></ul></p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Intraoperative and postoperative use of colloids</span><p id="par0080" class="elsevierStylePara elsevierViewall">Van Der Linden et al&#46;<a class="elsevierStyleCrossRef" href="#bib0365"><span class="elsevierStyleSup">26</span></a> evaluated the collateral effects of corn-derived HES 130&#47;0&#46;4 or potato-derived HES120&#47;0&#46;42 compared to other fluids &#40;gelatine&#44; albumin and crystalloids&#41;&#46; They included in their meta-analysis 59 randomly assigned studies and 4529 patients who had previous major cardiac and non-cardiac surgery&#44; trauma or burn patients&#46; They concluded that the use of HES 130&#47;0&#46;4 or 130&#47;0&#46;42 in these patients did not increase the risk for renal failure &#40;urine output&#44; serum creatinine&#44; or renal replacement therapy&#41;&#44; haemorrhage&#44; or mortality&#46; Patients who received HES 130&#47;0&#46;4 had less number of blood transfusions&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">Van der Linden et al&#46;<a class="elsevierStyleCrossRef" href="#bib0370"><span class="elsevierStyleSup">27</span></a> carried out a retrospective study with 1495 children that had cardiac surgery with extracorporeal circulation&#46; They compared patients who received crystalloids together with HES 130&#47;0&#46;4 &#40;exclusively derived from corn&#41; with albumin during their hospital stay&#46; The study concluded that weight gain&#44; bleeding and transfusion needs were less frequent in children who received HES 130&#47;0&#46;4 compared to those who received albumin alone&#46; No differences in postoperative serum creatinine&#44; therapy needs&#44; morbidity and mortality&#44; were found&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">The meta-analysis conducted by Martin et al&#46;<a class="elsevierStyleCrossRef" href="#bib0375"><span class="elsevierStyleSup">28</span></a> studied the impact on renal morbidity after the administration of crystalloids together with HES 130&#47;0&#46;4 &#40;only HES derived from corn&#41;&#44; compared to another alternative in the postoperative period in different scheduled surgeries&#46; They analyzed 17 randomly assigned studies that included 1230 patients&#46; In this study it was confirmed that the HES 130&#47;0&#46;4 had no association with any increase in serum creatinine&#44; any decrease in renal clearance or the need for renal replacement therapy &#40;RRT&#41;&#46; This meta-analysis only compared HES 130&#47;0&#46;4 derived from corn&#46; However&#44; it included studies with less tan 150 patients and a follow-up &#8804;24<span class="elsevierStyleHsp" style=""></span>h in the third part of the studies&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">The systematic review of Gillies et al&#46;<a class="elsevierStyleCrossRef" href="#bib0380"><span class="elsevierStyleSup">29</span></a> compared the effect of HES 130&#47;0&#46;4 or HES 130&#47;0&#46;42 to an another alternative&#44; in terms of mortality and renal morbidity &#40;development of renal failure and the need for RRT&#41;&#44; in the postoperative period after cardiac and non-cardiac surgery&#46; They included 1567 patients from 19 randomly selected studies&#46; They did not find any increase in mortality&#44; renal failure&#44; or RTT in the HES 130&#47;0&#46;4 group&#46; Nevertheless&#44; the authors did not find any benefits and concluded that there were not enough data to suggest the HES 130&#47;0&#46;4 as a routine therapy for surgical patients&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">The Wilkes and Navickis<a class="elsevierStyleCrossRef" href="#bib0385"><span class="elsevierStyleSup">30</span></a> meta-analysis included 15 randomly selected studies that investigated the need for RRT after major cardiac and non-cardiac surgery where other alternatives &#40;except haemoglobin substitutes&#41; were compared to HES&#46; 4409 patients were included of whom 2872 belonged to CHEST study &#40;65&#37;&#41;&#44; and in 362 patients high molecular weight HES were administered&#46; Eighty-three from a total of 2157 patients &#40;3&#46;8&#37;&#41; needed RRT while in 56 cases from a total of 2252 &#40;2&#46;5&#37;&#41; from control group needed RRT&#46; A higher need for RRT was observed in the HES group compared to crystalloids and concluded that after treating 85 patients with HES one patients would need RRT compared to those treated with crystalloids&#46; However&#44; this conclusion can be explained by the use of HES 200&#47;0&#46;62 and 450&#47;0&#46;7 which can accumulate and originate more incidence of renal failure than HES 130&#47;0&#46;4&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">The He et al&#46;<a class="elsevierStyleCrossRef" href="#bib0390"><span class="elsevierStyleSup">31</span></a> study&#44; evaluated the incidence of mortality in the ICU patients without sepsis&#44; using HES 6&#37; compared to other alternatives such as gelatines &#40;31&#37;&#41;&#44; gelatines plus lactate &#40;9&#37;&#41; albumin &#40;13&#46;6&#37;&#41;&#44; albumin plus lactate &#40;4&#46;5&#37;&#41;&#44; gelatines plus albumin and lactate &#40;4&#46;5&#37;&#41; lactate &#40;9&#37;&#41;&#44; saline &#40;13&#46;6&#37;&#41;&#44; fresh frozen plasma &#40;4&#46;5&#37;&#41; and a non-specific crystalloid &#40;9&#37;&#41;&#46; 22 randomly assigned studies were included &#40;6064 patients&#44; of whom 3704 were surgical patients and 1016 were not&#41;&#46; 4720 of those patients belonged to the CHEST study &#40;who were selected because of the absence of sepsis&#44; although the surgical criteria was not taken into account&#41;&#46; This meta-analysis concluded that patients who were resuscitated using HES received less total fluid volume&#44; and presented better haemodynamic stability and had less weight gains without differences in mortality&#44; the need for RRT&#44; haemorrhage or transfusion compared to other alternatives&#46; However&#44; most of these studies had less than 150 patients&#44; except for the CHEST study&#44; and 426 patients received high molecular weight HES&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall">The multicentre randomized study of Brandstrup et al&#46;<a class="elsevierStyleCrossRef" href="#bib0395"><span class="elsevierStyleSup">32</span></a> studied the morbidity and mortality of 172 patients who had previous colorectal surgery&#44; comparing crystalloids plus HES 6&#37;&#44; in a restrictive regimen trying to keep a hydric balance close to zero&#44; to a non-restrictive regimen based on crystalloids where HES 6&#37; was only administered when the bleeding reached 500<span class="elsevierStyleHsp" style=""></span>ml&#46; In the group that received the restrictive regimen with HES 6&#37; a significant less number of cardiopulmonary complications was observed compared to the non-restrictive group&#46; Patients in this last group suffered an increase in total body weight between 3 and 7<span class="elsevierStyleHsp" style=""></span>kg&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall">The Moretti et al&#46;&#44;<a class="elsevierStyleCrossRef" href="#bib0400"><span class="elsevierStyleSup">33</span></a> Mythen<a class="elsevierStyleCrossRef" href="#bib0405"><span class="elsevierStyleSup">34</span></a> and Yates et al&#46;<a class="elsevierStyleCrossRef" href="#bib0410"><span class="elsevierStyleSup">35</span></a> randomized studies in patients after major non-cardiac elective surgery&#44; demonstrated that the intraoperative administration of crystalloids alone&#44; was associated with a higher total volume infusion&#44; with more presence of postoperative oedema&#44; more weight gains&#44; more intestinal dysfunction &#40;postoperative nausea and vomiting&#41; and with more cardiopulmonary related complications compared to HES 130&#47;0&#46;4 and crystalloid combination&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">Zeng et al&#46;<a class="elsevierStyleCrossRef" href="#bib0415"><span class="elsevierStyleSup">36</span></a> analyzed the impact of early goal-directed therapies in 60 hypertensive elderly patients who had gastrointestinal surgery&#46; Bolus of 200<span class="elsevierStyleHsp" style=""></span>ml of HES 130&#47;0&#46;476&#37; were administered when systolic volume variations were &#60;13&#37;&#44; and inotrope agents were administered if no response was observed&#46; No differences were found in cardiac complications&#46; However&#44; the intraoperative administration of crystalloids together with boluses of HES 130&#47;0&#46;4 and the use of inotropes&#44; was associated with a greater haemodynamic stability&#44; a slower rate of volume infusion&#44; less postoperative oedema&#44; less intestinal dysfunction&#44; and shorter hospital stay compared to the classic crystalloid strategy&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">The randomized double-blind study of Kancir et al&#46;<a class="elsevierStyleCrossRef" href="#bib0420"><span class="elsevierStyleSup">37</span></a> was performed in 40 patients who had previous radical prostatectomy&#46; HES 130&#47;0&#46;4 6&#37; vs&#46; saline 0&#46;9&#37;&#59; &#40;7&#46;5<span class="elsevierStyleHsp" style=""></span>ml&#47;kg&#41; was administered during the first hour of surgery&#44; followed by HES vs&#46; saline for the next hours with a dose of 5<span class="elsevierStyleHsp" style=""></span>ml&#47;kg&#46; They concluded that the use of HES 130&#47;0&#46;4 compared to saline did not cause any impairment in the biochemical parameters for renal failure&#46; However&#44; patients treated with HES showed a greater mean arterial pressure and patients treated with saline alone showed significant lower levels of vasopressin and aldosterone&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">Kimberger et al&#46;<a class="elsevierStyleCrossRef" href="#bib0425"><span class="elsevierStyleSup">38</span></a> studied the impact of different strategies of goal-directed therapy on intestinal microvasculature in an animal model that had laparoscopic colon resection&#46; They could conclude that when central venous saturation was lower than 60&#37;&#44; a Ringer lactate plus HES 130&#47;0&#46;4 6&#37; infusion could considerably increase tissues oxygen content and perfusion in the peri-anastomotic microcirculation&#44; compared to a single bolus of ringer lactate or no fluid administration&#46;</p><p id="par0135" class="elsevierStylePara elsevierViewall">Cui et al&#46;<a class="elsevierStyleCrossRef" href="#bib0430"><span class="elsevierStyleSup">39</span></a> analyzed the impact of replacing blood loss with HES 6&#37; with a 1 to 1 proportion with two types of HES&#58; 130&#47;0&#46;4 vs&#46; 200&#47;0&#46;5&#46; Thirty patients scheduled for hepatic surgery with a significant haemorrhage were studied&#46; Intestinal microcirculation and clinical parameters were analyzed&#46; They demonstrated that HES 130&#47;0&#46;4 6&#37; could increase tissue perfusion and oxygen content in the intestinal microvasculature and decrease the time for the first bowel sound to appear and hospital stay&#44; compared to HES 200&#47;0&#46;5&#46;</p><p id="par0140" class="elsevierStylePara elsevierViewall">Regarding patients who had kidney transplant&#44; Legendre et al&#46;<a class="elsevierStyleCrossRef" href="#bib0435"><span class="elsevierStyleSup">40</span></a> found anatomical lesions due to a tubular starch accumulation &#8216;nephrosis-like&#8217; in 80&#37; of the kidneys from patients after brain death who had received HES 200&#47;0&#46;65&#46;</p><p id="par0145" class="elsevierStylePara elsevierViewall">The Cittanova et al&#46;<a class="elsevierStyleCrossRef" href="#bib0440"><span class="elsevierStyleSup">41</span></a> and Blasco et al&#46;<a class="elsevierStyleCrossRef" href="#bib0445"><span class="elsevierStyleSup">42</span></a> studies compared the complications of patients with previous kidney transplant from patients who suffered brain death that had been administered HEA 130&#47;0&#46;4 and HEA 200&#47;0&#46;65 before&#46; They found that patients who had kidney transplant from donors who had received HEA 130&#47;0&#46;65 or 0&#46;42 had lower levels of serum creatinine and better renal function for a year after the transplant compared to the administration of HEA 200&#47;0&#46;65&#46;</p><p id="par0150" class="elsevierStylePara elsevierViewall">One prospective study<a class="elsevierStyleCrossRef" href="#bib0450"><span class="elsevierStyleSup">43</span></a> included patients who had a previous kidney transplant and evaluated the impact that the treatment with HES caused on the donors who suffered brain death&#46; 986 patients were included &#40;529 from donors with brain death&#41; and 42&#37; of those who had kidney transplant received HES&#46; The use of HES&#44; the age&#44; the warm ischaemia time&#44; and previous creatinine in the donors was found an independent factor for the need of dialysis during the first post-transplant week&#46;</p><p id="par0155" class="elsevierStylePara elsevierViewall">In conclusion&#44; all these studies suggest that in surgical patients presenting haemorrhage&#44; the attempt to replace the loss of fluid from the intravascular compartment using crystalloids exclusively&#44; is associated with more interstitial oedema&#44; more weight gains and a worse oxygen utilization by the tissues&#46;<a class="elsevierStyleCrossRefs" href="#bib0400"><span class="elsevierStyleSup">33&#8211;36</span></a> In abdominal surgery this can also increase bowel transit time thus increasing the risk for wound dehiscence&#46;</p><p id="par0160" class="elsevierStylePara elsevierViewall">Furthermore&#44; these studies verify the safety of HES 130&#47;0&#46;4 when it is correctly administered using the lowest effective dose &#40;no more than 30<span class="elsevierStyleHsp" style=""></span>ml&#47;kg and no longer than 24<span class="elsevierStyleHsp" style=""></span>h&#41;&#46; They should also not be administered when the patient suffers from renal failure&#44; or cardiac&#44; liver failure&#44; coagulopathy or intracranial haemorrhage&#46; If the adequate dose is administered and no haemodynamic stability is reached&#44; vasopressors may be a useful alternative&#46; So in the surgical context &#40;except for brain-dead kidney donors&#41; HES 130&#47;0&#46;4 6&#37; does not produce more incidence of renal failure&#44; need for renal replacement therapy&#44;<a class="elsevierStyleCrossRefs" href="#bib0365"><span class="elsevierStyleSup">26&#8211;29&#44;44</span></a> coagulopathy<a class="elsevierStyleCrossRefs" href="#bib0365"><span class="elsevierStyleSup">26&#44;29&#44;44</span></a> or more incidence of mortality<a class="elsevierStyleCrossRefs" href="#bib0365"><span class="elsevierStyleSup">26&#44;29&#44;44</span></a> when HES 130&#47;0&#46;4&#8211;0&#46;42&#47;6&#37; are administered together with saline compared to unbalanced crystalloids&#46;</p><p id="par0165" class="elsevierStylePara elsevierViewall">This could encouraged the European Medicines Agency to keep the indication of HES 130&#47;0&#46;4&#8211;0&#46;42 for important bleeding&#44; so practitioners could be more inclined to choose this starch based on the benefits and its safety despite its high cost&#46;<a class="elsevierStyleCrossRef" href="#bib0460"><span class="elsevierStyleSup">45</span></a></p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Use of HES 130&#47;0&#46;4 with a balanced solution vs&#46; balanced crystalloid in the postoperative period</span><p id="par0170" class="elsevierStylePara elsevierViewall">Feldheiser et al&#46;<a class="elsevierStyleCrossRef" href="#bib0465"><span class="elsevierStyleSup">46</span></a> conducted a randomized double-blind trial in 50 patients with ovarian cancer where a goal-directed therapy was used based on a Doppler ultrasound technique during surgery time&#46; Patients were administered balanced crystalloids or HES 13070&#46;4&#47;6&#37; in a balanced solution&#46; They concluded that the intraoperative administration of HES 130&#47;0&#46;4&#47;6&#37; alone in a balanced solution together with the use of inotropes in a goal-directed therapy is associated with a more stable haemodynamic profile&#44; lower total volume fluid administration&#44; less plasma needs&#44; and less postoperative oedema compared to a goal-directed therapy using crystalloids alone&#46; Furthermore&#44; no renal failure incidence was observed and no mortality rate increased&#46; The number of blood transfusions was lower using HES 130&#47;0&#46;4 compared to a crystalloids regimen&#46;</p><p id="par0175" class="elsevierStylePara elsevierViewall">Krebbel et al&#46;<a class="elsevierStyleCrossRef" href="#bib0470"><span class="elsevierStyleSup">47</span></a> conducted a randomized double-blind study in 40 patients who were scheduled for total hip arthroplasty under general anaesthesia and using a goal-directed therapy based on Doppler ultrasound&#46; The algorithm was conducted following systolic volume&#59; once it was decreased a bolus of fluid was administered every 5<span class="elsevierStyleHsp" style=""></span>min as long as the systolic volume increased 10&#37;&#46; Vasopressors and inotrope agents to keep arterial mean pressure in each group were used&#46; Patients were randomly assigned to one group where boluses of 200<span class="elsevierStyleHsp" style=""></span>ml of saline 0&#46;9&#37; were used compared to the other group where boluses of 200<span class="elsevierStyleHsp" style=""></span>ml of HES 130&#47;0&#46;42&#47;6&#37; with a balanced solution were administered&#46; The study revealed that patients receiving saline presented more acidosis after surgery and a base excess more negative compared to patients who received balanced crystalloids and HES 130&#47;0&#46;42 &#40;base excess&#58; &#8722;2&#46;0<span class="elsevierStyleHsp" style=""></span>mmol&#47;l &#40;&#8722;3&#46;1 to &#8722;1&#46;1&#41; versus base excess&#58; &#8722;0&#46;4<span class="elsevierStyleHsp" style=""></span>mmol&#47;l &#40;&#8722;1&#46;2 to 0&#46;7&#41;&#44; respectively&#41;&#46; According to Stewart equations&#44; the most negative value of the base excess in the saline group was due to an excess of chloride ion&#44; while no differences in lactate and albumin levels were found&#46; Furthermore&#44; the intraoperative administration of HES 130&#47;0&#46;42&#47;6&#37; in a balanced solution together with inotrope agents under a goal-directed therapy was associated with a better haemodynamic stability&#44; less fluid volume administration and less plasma administration along with less postoperative oedema compared to the goal-directed therapy group with crystalloids&#46; No renal impairment or more transfusion were observed with HES 130&#47;0&#46;42 compared to a saline solution alone&#46;</p><p id="par0180" class="elsevierStylePara elsevierViewall">In summary&#44; HES 130&#47;0&#46;4&#47;6&#37; administered together with a balanced solution and balanced crystalloids could prevent hyperchloremic acidosis and its deleterious consequences in the surgical context&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Conclusions</span><p id="par0185" class="elsevierStylePara elsevierViewall">According to the conflicting results from the current published studies&#44; it is difficult to establish strong recommendations based on a good level of evidence&#44; so more publications are needed to determine the exact role of starches in the surgical patient&#46; Regarding the topic analyzed&#44; there a few on-going studies&#44; as the FLASH STUDY &#40;ClinicalTrials&#46;gov&#46; <a id="intr0005" class="elsevierStyleInterRef" href="https://clinicaltrials.gov/NCT02502773">NCT02502773</a>&#41; which compares the impact of postoperative complications related to HES 130&#47;04 administration vs&#46; saline in a goal-directed therapy protocol for abdominal surgery&#46; Other studies that are evaluating renal function when starches are used for patients in orthopaedic surgery &#40;<a id="intr0010" class="elsevierStyleInterRef" href="https://clinicaltrials.gov/NCT02361736">NCT02361736</a>&#41;&#44; prostatectomy &#40;VORA <a id="intr0015" class="elsevierStyleInterRef" href="https://clinicaltrials.gov/NCT01486563">NCT01486563</a>&#41; and laparoscopic nephrectomy &#40;VONE <a id="intr0020" class="elsevierStyleInterRef" href="https://clinicaltrials.gov/NCT01486550">NCT01486550</a>&#41; are also being performed&#46;</p><p id="par0190" class="elsevierStylePara elsevierViewall">However&#44; HES 130&#47;0&#46;4 has shown better results when compared to crystalloids in surgical or traumatic haemorrhage&#44; hypovolemic patients and tissue hypoperfusion syndrome since HES 130&#47;0&#46;4 can keep adequate tissue oxygen levels and efficient tissue perfusion&#44; using lower volumes of fluid&#46;</p><p id="par0195" class="elsevierStylePara elsevierViewall">Nonetheless&#44; the PRAC recommendations should be followed in order to avoid secondary effects&#44; and starches should be used exclusively in hypovolemia caused by acute haemorrhage&#44; with the minimum effective dose and with a maximum dose of 30<span class="elsevierStyleHsp" style=""></span>ml&#47;kg for a period no longer than 24<span class="elsevierStyleHsp" style=""></span>h following strict renal function vigilance for&#44; at least&#44; 90 day&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Conflict of interests</span><p id="par0200" class="elsevierStylePara elsevierViewall">Rafael U&#241;a Orej&#243;n has occasionally received honoraria from Baxter&#44; Fresenius and Braum by lecturing in different forums&#46;</p><p id="par0205" class="elsevierStylePara elsevierViewall">The other authors declare no conflict of interest&#46;</p></span></span>"
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        0 => array:2 [
          "identificador" => "sec0005"
          "titulo" => "Introduction"
        ]
        1 => array:2 [
          "identificador" => "sec0010"
          "titulo" => "The objectives of fluid therapy&#58; which fluid should we administer&#63;"
        ]
        2 => array:2 [
          "identificador" => "sec0015"
          "titulo" => "How much fluid should we administer&#63;"
        ]
        3 => array:2 [
          "identificador" => "sec0020"
          "titulo" => "Intraoperative and postoperative use of colloids"
        ]
        4 => array:2 [
          "identificador" => "sec0025"
          "titulo" => "Use of HES 130&#47;0&#46;4 with a balanced solution vs&#46; balanced crystalloid in the postoperative period"
        ]
        5 => array:2 [
          "identificador" => "sec0030"
          "titulo" => "Conclusions"
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        6 => array:2 [
          "identificador" => "sec0035"
          "titulo" => "Conflict of interests"
        ]
        7 => array:1 [
          "titulo" => "References"
        ]
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    "fechaRecibido" => "2015-10-29"
    "fechaAceptado" => "2016-03-02"
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Article information

ISSN: 00349356
Original language: English

DOI:10.1016/j.redar.2016.03.003

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