TY - JOUR
T1 - 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)
T2 - Study protocol, design and rationale for a double-blinded, randomised clinical trial
AU - Perner, Anders
AU - Haase, Nicolai
AU - Wetterslev, Jørn
AU - Åneman, Anders
AU - Tenhunen, Jyrki
AU - Guttormsen, Anne B.
AU - Klemenzson, Gudmundur
AU - Pott, Frank
AU - Bødker, Karen D.
AU - Bådstøløkken, Per M.
AU - Bendtsen, Asger
AU - Søe-Jensen, Peter
AU - Tousi, Hamid
AU - Bestle, Morten
AU - Pawlowicz, Malgorzata
AU - Winding, Robert
AU - Bülow, Hans Henrik
AU - Kancir, Claude
AU - Steensen, Morten
AU - Nielsen, Jonas
AU - Fogh, Bjarne
AU - Madsen, Kristian R.
AU - Larsen, Nils H.
AU - Carlsson, Marcela
AU - Wiis, Jørgen
AU - Petersen, John A.
AU - Iversen, Susanne
AU - Schøidt, Ole
AU - Leivdal, Siv
AU - Berezowicz, Pawel
AU - Pettilä, Ville
AU - Ruokonen, Esko
AU - Klepstad, Pål
AU - Karlsson, Sari
AU - Kaukonen, Maija
AU - Rutanen, Juha
AU - Karason, Sigurbergur
AU - Kjældgaard, Anne L.
AU - Holst, Lars B.
AU - Wernerman, Jan
N1 - Funding Information: We wish to thank the following: Clinical staff at all trial sites. The Scientific Committee: Simon Finfer (Sydney), Andre Vercueil (London), Lars S. Rasmussen (Copenhagen), Frank Brunkhorst (Jena). The Data Monitoring and Safety Committee: Daniel De Backer (Brussels), Peter Dalgaard (Copenhagen), Kathy Rowan (London). The 6S trial is supported by the Danish Medical Research Council (271-08-0691 and 09-066938), Rigshospitalets Research Council, Scandinavian Society of Anaesthesiology and Intensive Care Medicine (the ACTA foundation) and B Braun Medical AG. Funding Information: The trial is fully funded by the Danish Strategic Research Council, the Danish Research Council, Rig-shospitalet, the ACTA foundation and resources at trial sites. The funding sources have no influence on the trial design or data collection, management, analysis or reporting. The patients are covered by local insurance at the trial sites.
PY - 2011/1/27
Y1 - 2011/1/27
N2 - Background: By 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/Design: The 6S trial will randomise 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.
AB - Background: By 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/Design: The 6S trial will randomise 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.
UR - https://www.scopus.com/pages/publications/79251553749
U2 - 10.1186/1745-6215-12-24
DO - 10.1186/1745-6215-12-24
M3 - Article
C2 - 21269526
SN - 1745-6215
VL - 12
JO - Trials
JF - Trials
M1 - 24
ER -