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Hydroxyethyl Starch 130/0.4 Versus Ringer’s Acetate in Severe Sepsis
Study Questions:
What are the effects of hydroxyethyl starch 130/0.4 (HES) as compared with Ringer’s acetate on the composite outcome of death or end-stage kidney failure in patients with severe sepsis?
Methods:
In this multicenter, parallel-group, blinded trial, the investigators randomly assigned patients with severe sepsis to fluid resuscitation in the intensive care unit with either 6% HES 130/0.4 or Ringer’s acetate at a dose of up to 33 ml/kg of ideal body weight per day. The primary outcome measure was either death or end-stage kidney failure (dependence on dialysis) at 90 days after randomization.
Results:
Of the 804 patients who underwent randomization, 798 were included in the modified intention-to-treat population. The two intervention groups had similar baseline characteristics. At 90 days after randomization, 201 of 398 patients (51%) assigned to HES had died, as compared with 172 of 400 patients (43%) assigned to Ringer’s acetate (relative risk [RR], 1.17; 95% confidence interval [CI], 1.01-1.36; p = 0.03); one patient in each group had end-stage kidney failure. In the 90-day period, 87 patients (22%) assigned to HES were treated with renal-replacement therapy versus 65 patients (16%) assigned to Ringer’s acetate (RR, 1.35; 95% CI, 1.01-1.80; p = 0.04), and 38 patients (10%) and 25 patients (6%), respectively, had severe bleeding (relative risk, 1.52; 95% CI, 0.94-2.48; p = 0.09). The results were supported by multivariate analyses, with adjustment for known risk factors for death or acute kidney injury at baseline.
Conclusions:
The authors concluded that patients with severe sepsis assigned to fluid resuscitation with HES had an increased risk of death at day 90, and were more likely to require renal-replacement therapy, as compared with those receiving Ringer’s acetate.
Perspective:
In this international, blinded, randomized trial of fluid resuscitation of patients with severe sepsis, HES 130/0.4 significantly increased the risk of death or dependence on dialysis at day 90, as compared with Ringer’s acetate. The difference was due to an increased risk of death at 90 days, and HES 130/0.4 increased the absolute risk of death at 90 days by 8 percentage points, corresponding to a number needed to harm of 13. There appears to be little rationale for the use of HES 130/0.4 in severe sepsis, based on these data.
Keywords: Resuscitation, Multivariate Analysis, Sepsis, Acute Kidney Injury, Transcription Factors, Risk Factors, Critical Care, Hydroxyethyl Starch Derivatives, Renal Dialysis, Fluid Therapy, Cardiovascular Diseases, Isotonic Solutions, Confidence Intervals, Renal Replacement Therapy, Renal Insufficiency, Chronic
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