Effects of hydroxyethyl starch 130/0.4 compared to a balanced crystalloid solution on mortality and kidney failure in patients with severe sepsis - The 6S Trial

Dept. of Intensive Care, Rigshospitalet0 个研究点目标入组 800 人开始时间: 2009年3月23日最近更新: 2013年4月22日

适应症

试验速览

暂无简介。

•All adult patients who
•·Undergo resuscitation in the ICU
•·AND fulfilment within the previous 24 hours of the criteria for severe sepsis according to the Society of Critical Care Medicine/American College of Chest Physicians (SCCM/ACCP), see Appendix 1
•·AND consent is obtainable either from the patient or by proxy (physician and/or next of kin)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•·Age < 18 years
•·Previously randomised in the 6S trial
•·Allergy towards hydroxyethyl starch or malic acid
•·Treatment with > 1000 ml’s of any synthetic colloid within the last 24 hours prior to randomisation
•·Any form of renal replacement therapy
•·Acute burn injury > 10% body surface area
•·Severe hyperkalaemia, p-K > 6.0 mM
•·Liver or kidney transplantation during current hospital admission
•·Intracranial bleeding within current hospitalisation
•·Enrolment into another ICU trial of drugs with potential action on circulation, renal function or coagulation
•·Withdrawal of active therapy

发起方

Dept. of Intensive Care, Rigshospitalet