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01.12.2014 | Research | Ausgabe 6/2014 Open Access

Critical Care 6/2014

The impact of hydroxyethyl starches in cardiac surgery: a meta-analysis

Zeitschrift:
Critical Care > Ausgabe 6/2014
Autoren:
Matthias Jacob, Jean-Luc Fellahi, Daniel Chappell, Andrea Kurz
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13054-014-0656-0) contains supplementary material, which is available to authorized users.

Competing interests

The statistical analysis on which this work was based was conducted by the contract research organization M.A.R.C.O. at the request of, and supported by, Fresenius Kabi for presentation to the members of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) in order to provide the latest evidence in the article 31 and article 107i procedures. The statistical analysis conducted by M.A.R.C.O. was provided by Fresenius Kabi to the authors, who have written this manuscript independently from Fresenius Kabi. DC has held lectures and received research grants from B.Braun, Fresenius Kabi, GRIFOLS and LFB. MJ has held lectures for B.Braun, Baxter, Fresenius Kabi and Serumwerk Bernburg. He has received unrestricted research grants from CSL Behring, Fresenius Kabi and Serumwerk Bernburg. He is a member of the GRIFOLS Albumin Advisory Board. JLF has held lectures for Baxter and Fresenius Kabi. AK declares that she has no competing interests.

Authors’ contributions

MJ and JLF contributed equally to conception and design of the study and drafted the manuscript. MJ, JLF, DC and AK contributed to the interpretation of data and revised the manuscript. All authors read and approved the final manuscript.

Abstract

Introduction

Recent studies in septic patients showed that adverse effects of hydroxyethyl starches (HESs) possibly outweigh their benefits in severely impaired physiological haemostasis. It remains unclear whether this also applies to patient populations that are less vulnerable. In this meta-analysis, we evaluated the impact of various HES generations on safety and efficacy endpoints in patients undergoing cardiac surgery.

Methods

We searched the PubMed, Embase and Cochrane Central Register of Controlled Trials databases for randomised controlled trials (RCTs) in the English or German language comparing the use of HES to any other colloid or crystalloid during open heart surgery.

Results

Blood loss and transfusion requirements were higher for older starches with mean molecular weights more than 200 kDa compared to other volume substitutes. In contrast, this effect was not observed with latest-generation tetrastarches (130/0.4), which performed even better when compared to albumin (blood loss of tetrastarch versus albumin: standardised mean difference (SMD), −0.34; 95% CI, −0.63, −0.05; P = 0.02; versus gelatin: SMD, −0.06; 95% CI, −0.20, 0.08; P = 0.39; versus crystalloids: SMD, −0.05; 95% CI, −0.20, 0.10; P = 0.54). Similar results were found for transfusion needs. Lengths of stay in the intensive care unit or hospital were significantly shorter with tetrastarches compared to gelatin (intensive care unit: SMD, −0.10; 95% CI, −0.15, −0.05; P = 0.0002) and crystalloids (hospital: SMD, −0.52; 95% CI, −0.90, −0.14; P = 0.007).

Conclusions

In this meta-analysis of RCTs, we could not identify safety issues with tetrastarches compared with other colloid or crystalloid solutions in terms of blood loss, transfusion requirements or hospital length of stay in patients undergoing cardiac surgery. The safety data on coagulation with older starches raise some issues that need to be addressed in future trials.
Zusatzmaterial
Additional file 2: Blood loss with pentastarch compared to albumin, gelatin or crystalloids. Units of blood loss were millilitres (ml), except for Van der Linden et al. [52], where units were millilitres per kilogram body weight. The standardized mean difference of the mean for the pentastarch groups minus the mean for the albumin, gelatin and crystalloid groups was used as effect size. Fixed-effect models were applied to calculate a common effect estimate using the inverse variance method. Tigchelaar et al. [37] only report mean blood loss without presenting standard deviation (indicated by a ‘0’ in this figure). SD, Standard deviation; Std. mean difference, Standardized mean difference; IV, Inverse variance method; CI, Confidence interval. (JPEG 292 KB)
Additional file 3: Blood loss with hetastarch compared to albumin or crystalloids. Units of blood loss were millilitres (ml), except for Brutocao et al. [14], where units were millilitres per kilogram body weight (ml/kg), and Palanzo et al. [41], where no unit was indicated. The standardized mean difference of the mean for the hetastarch groups minus the mean for the albumin and crystalloid groups was used as effect size. Fixed-effects models were applied to calculate a common effect estimate using the inverse variance method. SD, Standard deviation; Std. mean difference, Standardized mean difference; IV, Inverse variance method; CI, Confidence interval. (JPEG 239 KB)
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