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dc.contributor.authorPerner, Anders*
dc.contributor.authorHaase, Nicolai*
dc.contributor.authorWetterslev, Jørn*
dc.contributor.authorAneman, Anders*
dc.contributor.authorTenhunen, Jyrki*
dc.contributor.authorGuttormsen, Anne Berit*
dc.contributor.authorKlemenzson, Gudmundur*
dc.contributor.authorPott, Frank*
dc.contributor.authorBødker, Karen Doris*
dc.contributor.authorBådstøløkken, Per Martin*
dc.contributor.authorBendtsen, Asger*
dc.contributor.authorSøe-Jensen, Peter*
dc.contributor.authorTousi, Hamid*
dc.contributor.authorBestle, Morten*
dc.contributor.authorPawlowicz, Malgorzata*
dc.contributor.authorWinding, Robert*
dc.contributor.authorBülow, Hans-Henrik*
dc.contributor.authorKancir, Claude*
dc.contributor.authorSteensen, Morten*
dc.contributor.authorNielsen, Jonas*
dc.contributor.authorFogh, Bjarne*
dc.contributor.authorMadsen, Kristian R*
dc.contributor.authorLarsen, Nils H*
dc.contributor.authorCarlsson, Marcela*
dc.contributor.authorWiis, Jørgen*
dc.contributor.authorPetersen, John Asger*
dc.contributor.authorIversen, Susanne*
dc.contributor.authorSchøidt, Ole*
dc.contributor.authorLeivdal, Siv*
dc.contributor.authorBerezowicz, Pawel*
dc.contributor.authorPettilä, Ville*
dc.contributor.authorRuokonen, Esko*
dc.contributor.authorKlepstad, Pål*
dc.contributor.authorKarlsson, Sari*
dc.contributor.authorKaukonen, Maija*
dc.contributor.authorRutanen, Juha*
dc.contributor.authorKarason, Sigurbergur*
dc.contributor.authorKjældgaard, Anne Lene*
dc.contributor.authorHolst, Lars Broksø*
dc.contributor.authorWernerman, Jan*
dc.date.accessioned2012-06-08T11:48:09Z
dc.date.available2012-06-08T11:48:09Z
dc.date.issued2011
dc.date.submitted2012-06-08
dc.identifier.citationTrials 2011, 12(1):24en_GB
dc.identifier.issn1745-6215
dc.identifier.pmid21269526
dc.identifier.doi10.1186/1745-6215-12-24
dc.identifier.urihttp://hdl.handle.net/2336/228056
dc.descriptionTo access publisher full text version of this article. Please click on the hyperlink in Additional Links field.en_GB
dc.description.abstractBACKGROUND: 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 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.
dc.description.sponsorshipDanish Medical Research Council 271-08-0691 09-066938 Rigshospitalets Research Council, Scandinavian Society of Anaesthesiology and Intensive Care Medicine (the ACTA foundation) B Braun Medical AGen_GB
dc.language.isoenen
dc.publisherBioMed Centralen_GB
dc.relation.urlhttp://dx.doi.org/10.1186/1745-6215-12-24en_GB
dc.relation.urlhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC3040153/?tool=pubmed
dc.rightsArchived with thanks to Trialsen_GB
dc.subject.meshAdulten_GB
dc.subject.meshDouble-Blind Methoden_GB
dc.subject.meshHetastarchen_GB
dc.subject.meshHumansen_GB
dc.subject.meshIsotonic Solutionsen_GB
dc.subject.meshMolecular Weighten_GB
dc.subject.meshPlasma Substitutesen_GB
dc.subject.meshRenal Insufficiencyen_GB
dc.subject.meshResearch Designen_GB
dc.subject.meshSepsisen_GB
dc.subject.meshSeverity of Illness Indexen_GB
dc.titleComparing 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.en
dc.typeArticleen
dc.contributor.departmentDepartment of Intensive Care, Centre of Clinical Intervention Research, Copenhagen University Hospital, Rigshospitalet, Denmark. anders.perner@rh.regionh.dken_GB
dc.identifier.journalTrialsen_GB
html.description.abstractBACKGROUND: 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 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.


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