Comparing the effect of hydroxyethyl starch 130/0.4 with balanced crystalloid solution on mortality and kidney failure in patients with severe sepsis (6S--Scandinavian Starch for Severe Sepsis/Septic Shock trial): study protocol, design and rationale for a double-blinded, randomised clinical trial.
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Perner Anders, Haase Nicolai, Wetterslev Jørn, Aneman Anders, Tenhunen Jyrki, Guttormsen Anne Berit, Klemenzson Gudmundur, Pott Frank, Bødker Karen Doris, Bådstøløkken Per Martin, Bendtsen Asger, Søe-Jensen Peter, Tousi Hamid, Bestle Morten, Pawlowicz Malgorzata, Winding Robert, Bülow Hans-Henrik, Kancir Claude, Steensen Morten, Nielsen Jonas, Fogh Bjarne, Madsen Kristian R, Larsen Nils H, Carlsson Marcela, Wiis Jørgen, Petersen John Asger, Iversen Susanne, Schøidt Ole, Leivdal Siv, Berezowicz Pawel, Pettilä Ville, Ruokonen Esko, Klepstad Pål, Karlsson Sari, Kaukonen Maija, Rutanen Juha, Karason Sigurbergur, Kjældgaard Anne Lene, Holst Lars Broksø, Wernerman Jan, Scandinavian Critical Care Trials Group
Аннотация
METHODS/DESIGN: The 6S trial will randomize 800 patients with severe sepsis in 30 Scandinavian ICUs to masked fluid resuscitation using either 6% HES 130/0.4 in Ringer's acetate or Ringer's acetate alone. The composite endpoint of 90-day mortality or end-stage kidney failure is the primary outcome measure. The secondary outcome measures are severe bleeding or allergic reactions, organ failure, acute kidney failure, days alive without renal replacement therapy or ventilator support and 28-day and 1/2- and one-year mortality. The sample size will allow the detection of a 10% absolute difference between the two groups in the composite endpoint with a power of 80%.
DISCUSSION: The 6S trial will provide important safety and efficacy data on the use of HES 130/0.4 in patients with severe sepsis. The effects on mortality, dialysis-dependency, time on ventilator, bleeding and markers of resuscitation, metabolism, kidney failure, and coagulation will be assessed.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT00962156.