• DOI:10.1056/NEJMoa1204242
• Corpus ID: 5893988

Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis.

@article{Perner2012HydroxyethylS1,
  title={Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis.},
  author={Anders Perner and Nicolai Haase and Anne Berit Guttormsen and Jyrki J. Tenhunen and Gudmundur K. Klemenzson and Anders Aneman and Kristian R{\o}rb{\ae}k Madsen and Morten Hylander M{\o}ller and Jeanie M Elkj{\ae}r and Lone M. Poulsen and Asger Bendtsen and Robert Winding and Morten Steensen and Pawel Berezowicz and Peter S{\o}e-Jensen and Morten H. Bestle and Kristian Strand and J{\o}rgen Wiis and Jonathan O White and Klaus J Thornberg and Lars Quist and Jonas Nielsen and Lasse H{\o}gh Andersen and Lars Broks{\o} Holst and Katrin Maria Thormar and Anne-Lene Kj{\ae}ldgaard and Maria Louise Fabritius and Frederik Mondrup and Frank Christian Pott and Thea Palsgaard M{\o}ller and Per Winkel and J{\o}rn Wetterslev},
  journal={The New England journal of medicine},
  year={2012},
  volume={367 2},
  pages={
          124-34
        }
}

• A. Perner, N. Haase, +29 authors J. Wetterslev
• Published 11 July 2012
• Medicine
• The New England journal of medicine

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.).