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

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 intensiv...

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Published in:	Current controlled trials in cardiovascular medicine Vol. 12; no. 1; p. 24
Main Authors:	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
Format:	Journal Article
Language:	English
Published:	England BioMed Central Ltd 27-01-2011 BioMed Central BMC
Subjects:	Acidosis Adult Anestesi och intensivvård Anesthesiology and Intensive Care Care and treatment chemistry Chloride Colloids in medicine Complications and side effects Consent Double-Blind Method Drug dosages drug therapy Electrolytes Family physicians Health aspects Hematology Hetastarch Hospitals Humans Hydroxyethyl Starch Derivatives - chemistry Hydroxyethyl Starch Derivatives - therapeutic use Intravenous therapy Isotonic Solutions Isotonic Solutions - chemistry Isotonic Solutions - therapeutic use Kidney diseases Kidney failure Medicin och hälsovetenskap Molecular Weight Mortality Patient outcomes Patients Plasma Substitutes Plasma Substitutes - chemistry Plasma Substitutes - therapeutic use Potassium Renal Insufficiency Renal Insufficiency - mortality Renal replacement therapy Research Design Risk factors Scandinavia Sepsis Sepsis - drug therapy Sepsis - mortality Severity of Illness Index Sodium Starch Study Protocol therapeutic use Ventilators Scandinavia
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Summary:	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. 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%. 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. ClinicalTrials.gov: NCT00962156.
ISSN:	1745-6215 1745-6215
DOI:	10.1186/1745-6215-12-24