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 fo
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- 作者：Anders Perner (1)
Nicolai Haase (1)
J?rn Wetterslev (2)
Anders ?neman (3)
Jyrki Tenhunen (4)
Anne Berit Guttormsen (5)
Gudmundur Klemenzson (6)
Frank Pott (7)
Karen Doris B?dker (8)
Per Martin B?dst?l?kken (9)
Asger Bendtsen (10)
Peter S?e-Jensen (11)
Hamid Tousi (11)
Morten Bestle (12)
Malgorzata Pawlowicz (13)
Robert Winding (14)
Hans-Henrik Bülow (15)
Claude Kancir (16)
Morten Steensen (17)
Jonas Nielsen (17)
Bjarne Fogh (18)
Kristian R Madsen (18)
Nils H Larsen (19)
Marcela Carlsson (19)
J?rgen Wiis (1)
John Asger Petersen (1)
Susanne Iversen (20)
Ole Sch?idt (20)
Siv Leivdal (21)
Pawel Berezowicz (22)
Ville Pettil? (23)
Esko Ruokonen (24)
P?l Klepstad (25)
Sari Karlsson (4)
Maija Kaukonen (23)
Juha Rutanen (24)
Sigurbergur Karason (6)
Anne Lene Kj?ldgaard (18)
Lars Broks? Holst (15)
Jan Wernerman (26) - 刊名：Trials
- 出版年：2011
- 出版时间：December 2011
- 年：2011
- 卷：12
- 期：1
- 全文大小：664KB
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Nicolai Haase (1)
J?rn Wetterslev (2)
Anders ?neman (3)
Jyrki Tenhunen (4)
Anne Berit Guttormsen (5)
Gudmundur Klemenzson (6)
Frank Pott (7)
Karen Doris B?dker (8)
Per Martin B?dst?l?kken (9)
Asger Bendtsen (10)
Peter S?e-Jensen (11)
Hamid Tousi (11)
Morten Bestle (12)
Malgorzata Pawlowicz (13)
Robert Winding (14)
Hans-Henrik Bülow (15)
Claude Kancir (16)
Morten Steensen (17)
Jonas Nielsen (17)
Bjarne Fogh (18)
Kristian R Madsen (18)
Nils H Larsen (19)
Marcela Carlsson (19)
J?rgen Wiis (1)
John Asger Petersen (1)
Susanne Iversen (20)
Ole Sch?idt (20)
Siv Leivdal (21)
Pawel Berezowicz (22)
Ville Pettil? (23)
Esko Ruokonen (24)
P?l Klepstad (25)
Sari Karlsson (4)
Maija Kaukonen (23)
Juha Rutanen (24)
Sigurbergur Karason (6)
Anne Lene Kj?ldgaard (18)
Lars Broks? Holst (15)
Jan Wernerman (26)
1. Department of Intensive Care, Centre of Clinical Intervention Research, Copenhagen University Hospital, Rigshospitalet, Denmark
2. Copenhagen Trial Unit, Centre of Clinical Intervention Research, Copenhagen University Hospital, Rigshospitalet, Denmark
3. Department of Intensive Care, Sahlgrenska University Hospital, G?teborg, Sweden
4. Critical Care Medicine Research Group, Tampere University Hospital, Tampere, Finland
5. Department of Intensive Care, Haukeland University Hospital, Bergen, Norway
6. Department of Intensive Care, Landspitalet, Reykjavik, Iceland
7. Department of Intensive Care, Bispebjerg Hospital, Copenhagen, Denmark
8. Department of Intensive Care, Esbjerg Hospital, Esbjerg, Denmark
9. Department of Intensive Care, Gentofte Hospital, Gentofte, Denmark
10. Department of Intensive Care, Glostrup Hospital, Glostrup, Denmark
11. Department of Intensive Care, Herlev Hospital, Herlev, Denmark
12. Department of Intensive Care, Hiller?d Hospital, Hiller?d, Denmark
13. Department of Intensive Care, Hj?rring Hospital, Hj?rring, Denmark
14. Department of Intensive Care, Herning Hospital, Herning, Denmark
15. Department of Intensive Care, Holb?k Hospital, Holb?k, Denmark
16. Department of Intensive Care, Holstebro Hospital, Holstebro, Denmark
17. Department of Intensive Care, Hvidovre Hospital, Hvidovre, Denmark
18. Department of Intensive Care, N?stved Hospital, N?stved, Denmark
19. Department of Intensive Care, Odense University Hospital, Odense, Denmark
20. Department of Intensive Care, Slagelse Hospital, Slagelse, Denmark
21. Department of Intensive Care, S?nderborg Hospital, S?nderborg, Denmark
22. Department of Intensive Care, Vejle Hospital, Vejle, Denmark
23. Department of Intensive Care, Helsinki University Hospital, Helsinki, Finland
24. Department of Intensive Care, Kuopio University Hospital, Kuopio, Finland
25. St. Olav’s University Hospital, Trondheim, Norway
26. Department of Intensive Care, Karolinska University Hospital, Karolinska, Sweden
文摘
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