Comparison of 6% hydroxyethyl starch 130/0.4 and saline solution for resuscitation of the microcirculation during the early goal-directed therapy of septic patients

Servicio de Terapia Intensiva, Sanatorio Otamendi y Miroli, Azcuénaga 870, Buenos Aires C1115AAB, Argentina.
Journal of critical care (Impact Factor: 2). 12/2010; 25(4):659.e1-8. DOI: 10.1016/j.jcrc.2010.04.007
Source: PubMed


The aim of this study was to show that 6% hydroxyethyl starch (HES) 130/0.4 achieves a better resuscitation of the microcirculation than normal saline solution (SS), during early goal-directed therapy (EGDT) in septic patients.
Patients with severe sepsis were randomized for EGDT with 6% HES 130/0.4 (n = 9) or SS (n = 11). Sublingual microcirculation was evaluated by sidestream dark field imaging 24 hours after the beginning of EGDT.
On admission, there were no differences in Sequential Organ Failure Assessment score, mean arterial pressure, lactate, or central venous oxygen saturation. After 24 hours, no difference arose in those parameters. Sublingual capillary density was similar in both groups (21 ± 8 versus 20 ± 3 vessels/mm(2)); but capillary microvascular flow index, percent of perfused capillaries, and perfused capillary density were higher in 6% HES 130/0.4 (2.5 ± 0.5 versus 1.6 ± 0.7, 84 ± 15 versus 53 ± 26%, and 19 ± 6 versus 11 ± 5 vessels/mm(2), respectively, P < .005).
Fluid resuscitation with 6% HES 130/0.4 may have advantages over SS to improve sublingual microcirculation. A greater number of patients would be necessary to confirm these findings.

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    • "Although an improvement of sublingual microcirculation after resuscitation with HES 130/0.4 versus saline was reported [24], septic patients receiving HES 130 were more likely to develop acute kidney injury, requiring renal replacement therapy, and to be at increased risk of death after 90 days [25]. This is in line with the findings in a large multicenter trial in which it was shown in 7,000 patients that the application of HES 130/0.4 "
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    ABSTRACT: There are limited data on the efficacy of early fluid resuscitation with third generation hydroxyethyl starch (HES 130) in burn injury. Adverse effects of HES on survival and organ function have been reported. In this randomized, controlled, double-blind trial 48 patients with severe burn injury were assigned to receive either Lactated Ringer's solution plus 6% HES 130/0.4 in a ratio of 2:1 or Lactated Ringer's solution with no colloid supplement for the first 72 hours. Primary outcome parameter was the group difference of administered total fluid from intensive care unit (ICU) admission up to day 3. Secondary outcomes included kidney and lung injury and failure, length of stay, and mortality. 3 days total of administered resuscitation fluid (medians) was 21,190 ml in the Lactated Ringer's group and 19,535 ml in the HES group (HES: -1,213 ml; P = 0.39). Creatinine levels day 1 to 3 (HES: +0.4 mumol/l; 95% CI -18.7 to 19.5; P = 0.97) and urinary output day 1 to 3 (HES: -58 ml; 95% CI -400 to 284; P = 0.90) were not different. 6 patients in each group developed acute respiratory distress syndrome (ARDS) (risk ratio 0.96; 95% CI 0.35 to 2.64; P = 0.95). Length of ICU stay (HES vs. Lactated Ringer's: 28 vs. 24 days; P = 0.80) and length of hospital stay (31 vs. 29 days; P = 0.57) were similar. 28-day mortality was 4 patients in each group (risk ratio 0.96; 95% CI 0.27 to 4.45; P = 0.95), in-hospital mortality was 8 in the HES group vs. 5 patients in the Lactated Ringer's group (hazard ratio 1.86; 95% CI 0.56 to 6.19; P = 0.31). There was no evidence that early fluid resuscitation with balanced HES 130/0.4 (6%) in addition to Lactated Ringer's solution would lead to a volume sparing effect in severe burn injury. Together with the findings that early renal function, incidence of ARDS, length of stay, and mortality were not negatively influenced by HES in this setting, balanced HES 130/0.4 (6%) plus Lactated Ringer's solution could not be considered superior to Lactated Ringer's solution alone.Trial registration: NCT01012648.
    Full-text · Article · Dec 2013 · Critical care (London, England)
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    • "respectively). ICU mortality was lower in the starch group when analyzing only randomized controlled trials, however this result was due to the inclusion of the studies by Dubin et al [9], and Lv et al [13], that were both of low quality (RR, 0.42 [95% CI, 0.24- 0.73]) [13] [14] (Fig. E2). AKI was higher in the group of HES in all subgroup analyses with the exception in studies where the colloid infusion on the first day was less than 1500 mL (RR, 1.20 [95% CI, 0.98-1.47]). "
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    ABSTRACT: Fluid resuscitation is a key intervention in sepsis, but the type of fluids used varies widely. The aim of this meta-analysis is to determine whether resuscitation with hydroxyethyl starches (HES) compared with crystalloids affects outcomes in patients with sepsis. Search of MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials up to February 2013. Studies that compared resuscitation with HES versus crystalloids in septic patients, and reported incidence of acute kidney injury (AKI), renal replacement therapy (RRT), transfusion of red blood cell (RBC) or fresh frozen plasma and/or mortality. Three investigators independently extracted data into uniform risk ratio measures. The Grading of Recommendations Assessment, Development and Evaluation framework was used to determine the quality of the evidence. Ten trials (4624 patients) were included. An increased incidence of AKI (risk ratio [RR], 1.24 [95% Confidence Interval {CI}, 1.13-1.36], and need of RRT (RR, 1.36 [95% CI, 1.17-1.57]) was found in patients who received resuscitation with HES. Resuscitation with HES was also associated with increased transfusion of RBC (RR, 1.14 [95% CI, 1.01-1.93]), but not fresh frozen plasma (RR, 1.47 [95% CI, 0.97-2.24]). Furthermore, while intensive care unit mortality (RR, 0.74 [95% CI, 0.43-1.26]), and 28-day mortality (RR, 1.11 [95% CI, 0.96-1.28]) was not different, resuscitation with HES was associated with higher 90-day mortality (RR, 1.14 [95% CI, 1.04-1.26]). Fluid resuscitation practice with HES as in the meta-analyzed studies is associated with increased an increase in AKI incidence, need of RRT, RBC transfusion, and 90-day mortality in patients with sepsis. Therefore, we favor the use of crystalloids over HES for resuscitation in patients with sepsis.
    Full-text · Article · Oct 2013 · Journal of critical care
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    • "However, in the majority of studies [1-4,7,18,20,21], we could not fully reproduce adequate indicators for haemodynamic instability, hypovolaemia, nor increased lactate from published baseline data, respectively. Only three trials [5,6,19] reported data on clinical signs that reasonably indicate hypovolaemia, thereby demonstrating that criteria for 'presumably correct indication' were met. "
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    ABSTRACT: Hydroxyethyl starch (HES) is a commonly used colloid in critically ill patients. However, its safety has been questioned in recent studies and meta-analyses. We re-evaluated prospective randomised controlled trials (RCT) from four meta-analyses published in 2013 which compared the effect of HES with crystalloids in critically ill patients, focusing on the adherence to 'presumably correct indication'. Regarding the definition of 'presumably correct indication', studies were checked for the following six criteria (max. six points): short time interval from shock to randomisation (< 6 h), restricted use for initial volume resuscitation, use of any consistent algorithm for haemodynamic stabilisation, reproducible indicators of hypovolaemia, maximum dose of HES, and exclusion of patients with pre-existing renal failure or renal replacement therapy. Duration of fluid administration ranged from 90 min up to a maximum of 90 days. Four studies considered follow-up until 90-day mortality, three studies 28-/30-day mortality, whereas four studies reported only early mortality. Included studies showed a large heterogeneity of the indication score ranging between 1 to 4 points with a median (25%; 75% quartile) of 4 (2; 4). The most important question, whether or not HES may be harmful when it is limited to immediate haemodynamic stabilisation, cannot be answered yet in the absence of any study sufficiently addressing this question. In order to overcome the limitations of most of the previous studies, we now suggest an algorithm emphasising the strict indication of HES. Additionally, we give a list of suggestions that should adequately be considered in any prospective RCT in the field of acute volume resuscitation in critically ill patients.
    Full-text · Article · Jul 2013 · Critical care (London, England)
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