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): Study protocol, design and rationale for a double-blinded, randomised clinical trial

AU - Perner, Anders

AU - Haase, Nicolai

AU - Wetterslev, Jørn

AU - Aneman, Anders

AU - Tenhunen, Jyrki

AU - Guttormsen, Anne Berit

AU - Klemenzson, Gudmundur

AU - Pott, Frank Christian

AU - Bødker, Karen Doris

AU - Bådstøløkken, Per Martin

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 Andreas Goul

AU - Carlsson, Marcela

AU - Wiis, Jørgen

AU - Petersen, John Asger

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 Lene

AU - Holst, Lars Broksø

AU - Wernerman, Jan

AU - the Scandinavian Critical Care Trials Group

AU - Carlsson, Marcela

AU - Iversen, Susanne

AU - Holst, Lars Broksø

AU - Madsen, Kristian R

PY - 2011/1/1

Y1 - 2011/1/1

N2 - ABSTRACT: 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 - ABSTRACT: 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.

U2 - 10.1186/1745-6215-12-24

DO - 10.1186/1745-6215-12-24

M3 - Journal article

C2 - 21269526

VL - 12

SP - 24

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

ER -