Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis
Anders Perner, Nicolai Haase, Anne B Guttormsen, Jyrki Tenhunen, Gudmundur Klemenzson, Anders Åneman, Kristian R Madsen, Morten H Møller, Jeanie M Elkjær, Lone M Poulsen, Asger Bendtsen, Robert Winding, Morten Steensen, Pawel Berezowicz, Peter Søe-Jensen, Morten Bestle, Kristian Strand, Jørgen Wiis, Jonathan O White, Klaus J Thornberg, Lars Quist, Jonas Nielsen, Lasse H Andersen, Lars B Holst, Katrin Thormar, Anne-Lene Kjældgaard, Maria L Fabritius, Frederik Mondrup, Frank C Pott, Thea P Møller, Per Winkel, Jørn Wetterslev, 6S Trial Group, Scandinavian Critical Care Trials Group, Anders Perner, Nicolai Haase, Anne B Guttormsen, Jyrki Tenhunen, Gudmundur Klemenzson, Anders Åneman, Jørn Wetterslev, Anders Perner, Nicolai Haase, Jørn Wetterslev, Simon Finfer, Andre Vercueil, Lars S Rasmussen, Frank Brunkhorst, Daniel De Backer, Peter Dalgaard, Kathy Rowan, Anders Perner, Nicolai Haase, Jørn Wetterslev, A Perner, N Haase, M N Kjær, K R Uhre, V Knudsen, V Christiansen, A Schulze, J Wiis, J O White, K Thornberg, L Quist, F Sjøvall, N Wesche, N Reiter, I L Jarnvig, K R Madsen, A L Kjældgaard, M L Fabritius, F Mondrup, K F Sommer, L F Pedersen, M H Møller, F C Pott, J A Petersen, A Lindhardt, K Møller, A Haraldson, C Pedersen, H H Bülow, J M Elkjær, T P Møller, L H Andersen, L B Holst, J F Schmidt, S T Nielsen, F P Treschow, M Overgaard, H Ahlstrøm, S Grangaard, J H Bruun, S Larsen, L M Poulsen, M V Madsen, B Bang, A Bendtsen, R Winding, K V Jepsen, S Haubjerg, N Dey, J Hjørringsgaard, M Steensen, J Nielsen, C Albek, S Petersen, A Christensen, A Kristensen, P Berezowicz, P Søe-Jensen, H Tousi, M Bestle, K Nielsen, T Kold, K Grundahl, K Strand, O Larsen, S Iversen, O Schøidt, M Pawlowicz, M Kruse, H S Rasmussen, L O Nielsen, A B Guttormsen, B Sjøbø, S Leivdal, L M Ytrebø, J Tenhunen, S Karlsson, A Kukkurainen, S Kortelainen, M L Peltola, S Varila, K Thormar, P M Bådstøløkken, G Klemenzson, S Karason, V Pettilä, M Kaukonen, L Pettilä, S Sutinen, M Carlson, N H Lassen, U L Larsen, K D Jung, C Kancir, J Rutanen, E Ruokonen, S Rissanen, K Kontra, P Klepstad, R E Berthelsen, K D Bødker, B Dilling, Anders Perner, Nicolai Haase, Anne B Guttormsen, Jyrki Tenhunen, Gudmundur Klemenzson, Anders Åneman, Kristian R Madsen, Morten H Møller, Jeanie M Elkjær, Lone M Poulsen, Asger Bendtsen, Robert Winding, Morten Steensen, Pawel Berezowicz, Peter Søe-Jensen, Morten Bestle, Kristian Strand, Jørgen Wiis, Jonathan O White, Klaus J Thornberg, Lars Quist, Jonas Nielsen, Lasse H Andersen, Lars B Holst, Katrin Thormar, Anne-Lene Kjældgaard, Maria L Fabritius, Frederik Mondrup, Frank C Pott, Thea P Møller, Per Winkel, Jørn Wetterslev, 6S Trial Group, Scandinavian Critical Care Trials Group, Anders Perner, Nicolai Haase, Anne B Guttormsen, Jyrki Tenhunen, Gudmundur Klemenzson, Anders Åneman, Jørn Wetterslev, Anders Perner, Nicolai Haase, Jørn Wetterslev, Simon Finfer, Andre Vercueil, Lars S Rasmussen, Frank Brunkhorst, Daniel De Backer, Peter Dalgaard, Kathy Rowan, Anders Perner, Nicolai Haase, Jørn Wetterslev, A Perner, N Haase, M N Kjær, K R Uhre, V Knudsen, V Christiansen, A Schulze, J Wiis, J O White, K Thornberg, L Quist, F Sjøvall, N Wesche, N Reiter, I L Jarnvig, K R Madsen, A L Kjældgaard, M L Fabritius, F Mondrup, K F Sommer, L F Pedersen, M H Møller, F C Pott, J A Petersen, A Lindhardt, K Møller, A Haraldson, C Pedersen, H H Bülow, J M Elkjær, T P Møller, L H Andersen, L B Holst, J F Schmidt, S T Nielsen, F P Treschow, M Overgaard, H Ahlstrøm, S Grangaard, J H Bruun, S Larsen, L M Poulsen, M V Madsen, B Bang, A Bendtsen, R Winding, K V Jepsen, S Haubjerg, N Dey, J Hjørringsgaard, M Steensen, J Nielsen, C Albek, S Petersen, A Christensen, A Kristensen, P Berezowicz, P Søe-Jensen, H Tousi, M Bestle, K Nielsen, T Kold, K Grundahl, K Strand, O Larsen, S Iversen, O Schøidt, M Pawlowicz, M Kruse, H S Rasmussen, L O Nielsen, A B Guttormsen, B Sjøbø, S Leivdal, L M Ytrebø, J Tenhunen, S Karlsson, A Kukkurainen, S Kortelainen, M L Peltola, S Varila, K Thormar, P M Bådstøløkken, G Klemenzson, S Karason, V Pettilä, M Kaukonen, L Pettilä, S Sutinen, M Carlson, N H Lassen, U L Larsen, K D Jung, C Kancir, J Rutanen, E Ruokonen, S Rissanen, K Kontra, P Klepstad, R E Berthelsen, K D Bødker, B Dilling
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.).
Source: PubMed