New England Journal of Medicine· 2012Q1· Clinical trial
Hydroxyethyl Starch 130/0.42 versus Ringer's Acetate in Severe Sepsis
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- Q1SCImago
- 2012year
Short summary
In severe sepsis patients, fluid resuscitation with Hydroxyethyl Starch (HES) 130/0.42 led to a higher risk of death at 90 days (51% vs. 43%) and increased need for renal-replacement therapy compared to Ringer's acetate.
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Key points
- Severe sepsis patients receiving HES 130/0.42 had a 1.17 relative risk of death at 90 days (P=0.03).
- HES 130/0.42 group required renal-replacement therapy more often (22% vs. 16%, RR 1.35, P=0.04).
- Severe bleeding occurred in 10% of HES patients versus 6% of Ringer's acetate patients (RR 1.52, P=0.09).
- The trial involved 804 patients randomized across multiple centers.
AI-generated from the title and abstract; the full text is not read.
Abstract
BACKGROUND: Hydroxyethyl starch (HES) [corrected] is widely used for fluid resuscitation in intensive care units (ICUs), but its safety and efficacy have not been established in patients with severe sepsis. METHODS: In this multicenter, parallel-group, blinded trial, we randomly assigned patients with severe sepsis to fluid resuscitation in the ICU with either 6% HES 130/0.42 (Tetraspan) or Ringer's acetate at a dose of up to 33 ml per kilogram 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 130/0.42 had died, as compared with 172 of 400 patients (43%) assigned to Ringer's acetate (relative risk, 1.17; 95% confidence interval [CI], 1.01 to 1.36; P=0.03); 1 patient in each group had end-stage kidney failure. In the 90-day period, 87 patients (22%) assigned to HES 130/0.42 were treated with renal-replacement therapy versus 65 patients (16%) assigned to Ringer's acetate (relative risk, 1.35; 95% CI, 1.01 to 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 to 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: Patients with severe sepsis assigned to fluid resuscitation with HES 130/0.42 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. (Funded by the Danish Research Council and others; 6S ClinicalTrials.gov number, NCT00962156.).
The authors' abstract, as published at the source. New England Journal of Medicine, 2012 · DOI ↗
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Field: Critical Care and Intensive Care Medicine
Critical Care and Intensive Care MedicineMedicine