Giuseppe
Emeritus
[Source: The New England Journal of Medicine, full text: (LINK). Abstract, edited.]
Hydroxyethyl Starch 130/0.4 versus Ringer's Acetate in Severe Sepsis
Anders Perner, M.D., Ph.D., Nicolai Haase, M.D., Anne B. Guttormsen, M.D., Ph.D., Jyrki Tenhunen, M.D., Ph.D., Gudmundur Klemenzson, M.D., Anders ?neman, M.D., Ph.D., Kristian R. Madsen, M.D., Morten H. M?ller, M.D., Ph.D., Jeanie M. Elkj?r, M.D., Lone M. Poulsen, M.D., Asger Bendtsen, M.D., M.P.H., Robert Winding, M.D., Morten Steensen, M.D., Pawel Berezowicz, M.D., Ph.D., Peter S?e-Jensen, M.D., Morten Bestle, M.D., Ph.D., Kristian Strand, M.D., Ph.D., J?rgen Wiis, M.D., Jonathan O. White, M.D., Klaus J. Thornberg, M.D., Lars Quist, M.D., Jonas Nielsen, M.D., Ph.D., Lasse H. Andersen, M.D., Lars B. Holst, M.D., Katrin Thormar, M.D., Anne-Lene Kj?ldgaard, M.D., Maria L. Fabritius, M.D., Frederik Mondrup, M.D., Frank C. Pott, M.D., D.M.Sci., Thea P. M?ller, M.D., Per Winkel, M.D., D.M.Sci., and J?rn Wetterslev, M.D., Ph.D. for the 6S Trial Group and the Scandinavian Critical Care Trials Group
June 27, 2012 (10.1056/NEJMoa1204242)
Abstract
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.)
- ------Anders Perner, M.D., Ph.D., Nicolai Haase, M.D., Anne B. Guttormsen, M.D., Ph.D., Jyrki Tenhunen, M.D., Ph.D., Gudmundur Klemenzson, M.D., Anders ?neman, M.D., Ph.D., Kristian R. Madsen, M.D., Morten H. M?ller, M.D., Ph.D., Jeanie M. Elkj?r, M.D., Lone M. Poulsen, M.D., Asger Bendtsen, M.D., M.P.H., Robert Winding, M.D., Morten Steensen, M.D., Pawel Berezowicz, M.D., Ph.D., Peter S?e-Jensen, M.D., Morten Bestle, M.D., Ph.D., Kristian Strand, M.D., Ph.D., J?rgen Wiis, M.D., Jonathan O. White, M.D., Klaus J. Thornberg, M.D., Lars Quist, M.D., Jonas Nielsen, M.D., Ph.D., Lasse H. Andersen, M.D., Lars B. Holst, M.D., Katrin Thormar, M.D., Anne-Lene Kj?ldgaard, M.D., Maria L. Fabritius, M.D., Frederik Mondrup, M.D., Frank C. Pott, M.D., D.M.Sci., Thea P. M?ller, M.D., Per Winkel, M.D., D.M.Sci., and J?rn Wetterslev, M.D., Ph.D. for the 6S Trial Group and the Scandinavian Critical Care Trials Group
June 27, 2012 (10.1056/NEJMoa1204242)
Abstract
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.)