Randomised trials of 6 % tetrastarch (hydroxyethyl starch 130/0.4 or 0.42) for severe sepsis reporting mortality: systematic review and meta-analysis
File(s)
Author(s)
Patel, A
Waheed, U
Brett, SJ
Type
Journal Article
Abstract
Purpose
To assess the impact of 6 % tetrastarch [hydroxyethyl starch (HES) 130/0.4 and 130/0.42] in severe sepsis patients. The primary outcome measure was 90-day mortality.
Methods
A structured literature search was undertaken to identify prospective randomised controlled trials (RCTs) in adult patients with severe sepsis receiving 6 % tetrastarch (of potato or waxy maize origin) as part of fluid resuscitation in comparison with other non-HES fluids after randomisation in the critical care setting. A systematic review and meta-analysis were performed.
Results
Six RCTs were included (n = 3,033): three from 2012 (n = 2,913) had low risk of bias. Median tetrastarch exposure was 37.4 ml/kg (range 30–43 ml/kg). Ninety-day mortality was associated with tetrastarch exposure [relative risk (RR) 1.13; 95 % confidence interval (CI) 1.02–1.25; p = 0.02] compared with crystalloid. The number needed to harm (NNH) was 28.8 (95 % CI 14.6–942.5). Publication bias and statistical heterogeneity (I 2 = 0 %) were not present. Tetrastarch exposure was also associated with renal replacement therapy (p = 0.01; NNH 15.7) and allogeneic transfusion support (p = 0.001; NNH 9.9). No difference between groups was observed for 28-day mortality, for comparison with colloid as control, or for waxy maize-derived tetrastarch, but power was lacking. Overall mortality was associated with tetrastarch exposure (RR 1.13; 95 % CI 1.02–1.25; p = 0.02).
Conclusions
In our analysis, 6 % tetrastarch as part of initial fluid resuscitation for severe sepsis was associated with harm and, as alternatives exist, in our view should be avoided.
To assess the impact of 6 % tetrastarch [hydroxyethyl starch (HES) 130/0.4 and 130/0.42] in severe sepsis patients. The primary outcome measure was 90-day mortality.
Methods
A structured literature search was undertaken to identify prospective randomised controlled trials (RCTs) in adult patients with severe sepsis receiving 6 % tetrastarch (of potato or waxy maize origin) as part of fluid resuscitation in comparison with other non-HES fluids after randomisation in the critical care setting. A systematic review and meta-analysis were performed.
Results
Six RCTs were included (n = 3,033): three from 2012 (n = 2,913) had low risk of bias. Median tetrastarch exposure was 37.4 ml/kg (range 30–43 ml/kg). Ninety-day mortality was associated with tetrastarch exposure [relative risk (RR) 1.13; 95 % confidence interval (CI) 1.02–1.25; p = 0.02] compared with crystalloid. The number needed to harm (NNH) was 28.8 (95 % CI 14.6–942.5). Publication bias and statistical heterogeneity (I 2 = 0 %) were not present. Tetrastarch exposure was also associated with renal replacement therapy (p = 0.01; NNH 15.7) and allogeneic transfusion support (p = 0.001; NNH 9.9). No difference between groups was observed for 28-day mortality, for comparison with colloid as control, or for waxy maize-derived tetrastarch, but power was lacking. Overall mortality was associated with tetrastarch exposure (RR 1.13; 95 % CI 1.02–1.25; p = 0.02).
Conclusions
In our analysis, 6 % tetrastarch as part of initial fluid resuscitation for severe sepsis was associated with harm and, as alternatives exist, in our view should be avoided.
Date Issued
2013-02-22
Citation
Intensive Care Medicine, 2013, 39, pp.811-822
ISSN
0342-4642
Publisher
Springer-Verlag
Start Page
811
End Page
822
Journal / Book Title
Intensive Care Medicine
Volume
39
Copyright Statement
© 2013 Springer-Verlag Berlin Heidelberg and
ESICM. The original publication is available at www.springerlink.com
ESICM. The original publication is available at www.springerlink.com
Description
14.03.13 KB. Ok to add accepted version to spiral. Springer
Identifier
http://www.ncbi.nlm.nih.gov/pubmed/23430019
Subjects
6 % tetrastarch
6 % hydroxyethyl starch (HES) 130/0.4 or 0.42
Severe sepsis
Mortality
Renal
Publication Status
Published
Article Number
5