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Hydroxyethyl Starch 130/0.4 versus Ringer's Acetate in Severe Sepsis.
Perner, Anders M.D., Ph.D.; Haase, Nicolai M.D.; Guttormsen, Anne B. M.D., Ph.D.; Tenhunen, Jyrki M.D., Ph.D.; Klemenzson, Gudmundur M.D.; Aneman, Anders M.D., Ph.D.; Madsen, Kristian R. M.D.; Moller, Morten H. M.D., Ph.D.; Elkjaer, Jeanie M. M.D.; Poulsen, Lone M. M.D.; Bendtsen, Asger M.D., M.P.H.; Winding, Robert M.D.; Steensen, Morten M.D.; Berezowicz, Pawel M.D., Ph.D.; Soe-Jensen, Peter M.D.; Bestle, Morten M.D., Ph.D.; Strand, Kristian M.D., Ph.D.; Wiis, Jorgen M.D.; White, Jonathan O. M.D.; Thornberg, Klaus J. M.D.; Quist, Lars M.D.; Nielsen, Jonas M.D., Ph.D.; Andersen, Lasse H. M.D.; Holst, Lars B. M.D.; Thormar, Katrin M.D.; Kjaeldgaard, Anne-Lene M.D.; Fabritius, Maria L. M.D.; Mondrup, Frederik M.D.; Pott, Frank C. M.D., D.M.Sci.; Moller, Thea P. M.D.; Winkel, Per M.D., D.M.Sci.; Wetterslev, Jorn M.D., Ph.D.; the 6S Trial Group and the Scandinavian Critical Care Trials Group *
[Article] New England Journal of Medicine. 367(2):124-134, July 12, 2012.

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Background: Hydroxyethyl starch (HES) 130/0.4 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 130/0.4 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 130/0.4 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 130/0.4 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 130/0.4 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.)