• Anders Perner, Nicolai Haase, Jørn Wetterslev, Anders Aneman, Jyrki Tenhunen, Anne Berit Guttormsen, Gudmundur Klemenzson, Frank Pott, Karen Doris Bødker, Per Martin Bådstøløkken, Asger Bendtsen, Peter Søe-Jensen, Hamid Tousi, Morten Bestle, Malgorzata Pawlowicz, Robert Winding, Hans-Henrik Bülow, Claude Kancir, Morten Steensen, Jonas Nielsen, Bjarne Fogh, Kristian R Madsen, Nils H Larsen, Marcela Carlsson, Jørgen Wiis, John Asger Petersen, Susanne Iversen, Ole Schøidt, Siv Leivdal, Pawel Berezowicz, Ville Pettilä, Esko Ruokonen, Pål Klepstad, Sari Karlsson, Maija Kaukonen, Juha Rutanen, Sigurbergur Karason, Anne Lene Kjældgaard, Lars Broksø Holst, Jan Wernerman, and Scandinavian Critical Care Trials Group.
• Department of Intensive Care, Centre of Clinical Intervention Research, Copenhagen University Hospital, Rigshospitalet, Denmark. anders.perner@rh.regionh.dk
• Trials. 2011 Jan 1;12:24.

BackgroundBy tradition colloid solutions have been used to obtain fast circulatory stabilisation in shock, but high molecular weight hydroxyethyl starch (HES) may cause acute kidney failure in patients with severe sepsis. Now lower molecular weight HES 130/0.4 is the preferred colloid in Scandinavian intensive care units (ICUs) and 1st choice fluid for patients with severe sepsis. However, HES 130/0.4 is largely unstudied in patients with severe sepsis.Methods/DesignThe 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%.DiscussionThe 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 RegistrationClinicalTrials.gov: NCT00962156.

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