EUCTR2009-010104-28-FI进行中（未招募）1 期
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: 2010年2月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •·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
研究者
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