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

Anders Perner; Nicolai Haase; Jørn Wetterslev; Anders Aneman; Jyrki Tenhunen; Anne Berit Guttormsen; Gudmundur Klemenzson; Frank Christian 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 Andreas Goul 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; the Scandinavian Critical Care Trials Group; Marcela Carlsson; Susanne Iversen; Lars Broksø Holst; Kristian R Madsen

doi:10.1186/1745-6215-12-24

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

Anders Perner, Nicolai Haase, Jørn Wetterslev, Anders Aneman, Jyrki Tenhunen, Anne Berit Guttormsen, Gudmundur Klemenzson, Frank Christian 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 NielsenBjarne Fogh, Kristian R Madsen, Nils Andreas Goul 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, the Scandinavian Critical Care Trials Group, Marcela Carlsson, Susanne Iversen, Lars Broksø Holst, Kristian R Madsen

48 Citationer (Scopus)

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 1^stchoice 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.

Originalsprog	Engelsk
Tidsskrift	Trials
Vol/bind	12
Udgave nummer	1
Sider (fra-til)	24
ISSN	1745-6215
DOI	https://doi.org/10.1186/1745-6215-12-24 https://doi.org/10.1186/1745-6215-12-24
Status	Udgivet - 27 jan. 2011

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Citationsformater

Perner, A., Haase, N., Wetterslev, J., Aneman, A., Tenhunen, J., Guttormsen, A. B., Klemenzson, G., Pott, F. C., Bødker, K. D., Bådstøløkken, P. M., Bendtsen, A., Søe-Jensen, P., Tousi, H., Bestle, M., Pawlowicz, M., Winding, R., Bülow, H-H., Kancir, C., Steensen, M., ... Madsen, K. R. (2011). 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. Trials, 12(1), 24. https://doi.org/10.1186/1745-6215-12-24, https://doi.org/10.1186/1745-6215-12-24

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. / Perner, Anders; Haase, Nicolai; Wetterslev, Jørn et al.

I: Trials, Bind 12, Nr. 1, 27.01.2011, s. 24.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Perner, A, Haase, N, Wetterslev, J, Aneman, A, Tenhunen, J, Guttormsen, AB, Klemenzson, G, Pott, FC, Bødker, KD, Bådstøløkken, PM, Bendtsen, A, Søe-Jensen, P, Tousi, H, Bestle, M, Pawlowicz, M, Winding, R, Bülow, H-H, Kancir, C, Steensen, M, Nielsen, J, Fogh, B, Madsen, KR, Larsen, NAG, Carlsson, M, Wiis, J, Petersen, JA, Iversen, S, Schøidt, O, Leivdal, S, Berezowicz, P, Pettilä, V, Ruokonen, E, Klepstad, P, Karlsson, S, Kaukonen, M, Rutanen, J, Karason, S, Kjældgaard, AL, Holst, LB, Wernerman, J, the Scandinavian Critical Care Trials Group, Carlsson, M, Iversen, S, Holst, LB & Madsen, KR 2011, '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', Trials, bind 12, nr. 1, s. 24. https://doi.org/10.1186/1745-6215-12-24, https://doi.org/10.1186/1745-6215-12-24

Perner A, Haase N, Wetterslev J, Aneman A, Tenhunen J, Guttormsen AB et al. 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. Trials. 2011 jan. 27;12(1):24. doi: 10.1186/1745-6215-12-24, http://dx.doi.org/10.1186/1745-6215-12-24

Perner, Anders ; Haase, Nicolai ; Wetterslev, Jørn et al. / 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. I: Trials. 2011 ; Bind 12, Nr. 1. s. 24.

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title = "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",

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.",

author = "Anders Perner and Nicolai Haase and J{\o}rn Wetterslev and Anders Aneman and Jyrki Tenhunen and Guttormsen, {Anne Berit} and Gudmundur Klemenzson and Pott, {Frank Christian} and B{\o}dker, {Karen Doris} and B{\aa}dst{\o}l{\o}kken, {Per Martin} and Asger Bendtsen and Peter S{\o}e-Jensen and Hamid Tousi and Morten Bestle and Malgorzata Pawlowicz and Robert Winding and Hans-Henrik B{\"u}low and Claude Kancir and Morten Steensen and Jonas Nielsen and Bjarne Fogh and Madsen, {Kristian R} and Larsen, {Nils Andreas Goul} and Marcela Carlsson and J{\o}rgen Wiis and Petersen, {John Asger} and Susanne Iversen and Ole Sch{\o}idt and Siv Leivdal and Pawel Berezowicz and Ville Pettil{\"a} and Esko Ruokonen and P{\aa}l Klepstad and Sari Karlsson and Maija Kaukonen and Juha Rutanen and Sigurbergur Karason and Kj{\ae}ldgaard, {Anne Lene} and Holst, {Lars Broks{\o}} and Jan Wernerman and Pott, {Frank Christian} and Marcela Carlsson and Susanne Iversen and Holst, {Lars Broks{\o}} and Madsen, {Kristian R}",

year = "2011",

month = jan,

day = "27",

doi = "10.1186/1745-6215-12-24",

language = "English",

volume = "12",

pages = "24",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central Ltd.",

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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 - 2011/1/27

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.

U2 - 10.1186/1745-6215-12-24

DO - 10.1186/1745-6215-12-24

M3 - Journal article

C2 - 21269526

SN - 1745-6215

VL - 12

SP - 24

JO - Trials

JF - Trials

IS - 1

ER -