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Randomised trials of 6 % tetrastarch (hydroxyethyl starch 130/0.4 or 0.42) for severe sepsis reporting mortality: systematic review and meta-analysis

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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.

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Acknowledgments

We acknowledge the Medical Research Council (MRC) Chain–Florey Fellowship scheme based at the Clinical Sciences Centre, Imperial College London. The research was supported by the National Institute for Health Research (NIHR) Biomedical Research Centre based at Imperial College Healthcare NHS Trust and Imperial College London. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

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Authors and Affiliations

  1. Centre for Perioperative Medicine and Critical Care Research, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, UK

    Amit Patel, Umeer Waheed & Stephen J. Brett

  2. MRC Clinical Sciences Centre and Centre for Haematology, Imperial College London, Hammersmith Hospital, London, UK

    Amit Patel

  3. General Intensive Care Unit, Centre for Perioperative Medicine and Critical Care Research, Imperial College Healthcare NHS Trust, Hammersmith Hospital, Du Cane Road, London, W12 0HS, UK

    Amit Patel

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  1. Amit Patel
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Patel, A., Waheed, U. & Brett, S.J. Randomised trials of 6 % tetrastarch (hydroxyethyl starch 130/0.4 or 0.42) for severe sepsis reporting mortality: systematic review and meta-analysis. Intensive Care Med 39, 811–822 (2013). https://doi.org/10.1007/s00134-013-2863-6

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