NCT01149278已完成不适用
Assessment of Two Levels of Arterial Pressure on Survival in Patients With Septic Shock
University Hospital, Angers1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- mortality
研究概览
简要总结
The ideal mean arterial pressure in patients with septic shock is unknown. The expert's recommandations have stated a target between 65 and 70 mm Hg. However the scientific basis are weak. Indead there are only few prospective studies which addressed this question without clear answer. Therefore we designed a RCT in order to assess the effect on mortality of two levels of mean arterial pressure in patients with septic shock.(800 patients, 30 centres)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with septic shock according criteria of Bone
- •minimal dose of norepinephrine
- •Written informed consent obtained from the patient or surrogate
排除标准
- •Age < 18 years
- •Pregnancy
- •Participation in other trials with the same endpoints
- •absence of registration in french health care system
- •patient protected by law
研究组 & 干预措施
high pressure
Active Comparator
干预措施: maintain mean arterial pressure between 80-85 mm Hg (Drug)
normal pressure
Placebo Comparator
干预措施: maintain mean arterial pressure between 65-70 mm Hg (Other)
结局指标
主要结局
mortality
时间窗: day 28
次要结局
- renal function(day 1 to day 28)
- decrease in mortality at day 90(day 90)
- decrease in sequential organ failure assessment(day 1 to day 28)
- extra renal replacement free days(day 28)
- amount of fluids(day 1 to end of shock)
- catecholamines free days(day 1 to day 28)
研究者
研究点 (1)
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