Multicenter, Prospective, Randomized, Controlled Open Study Albumin 20% Versus Saline
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 794
- 试验地点
- 1
- 主要终点
- Mortality, any cause, during the 28 day period after randomization
研究概览
简要总结
Objective: To determine whether the early administration of albumin as an expander and antioxidant would improve survival on the 28th day for septic shock patients.
Design: Prospective, multicenter, randomized, controlled versus saline, stratified on nosocomial infection and center.
Setting: 27 Intensive Care Units (ICU) in France
Coordinator: Pr J.P. Mira and Dr J. Charpentier - Cochin Hospital- Paris
Patients: 800 patients could be included during the first 6 hours of their septic shock.
详细描述
The primary outcome: Mortality during the 28 day period after randomization. The secondary outcomes: Evaluation of SOFA score, ventilator-free days, dialysis free days, catecholamine free days, days of hospitalisation, incidence of nosocomial infections.
The albuminemia of all patients is requested before the treatment until Day 4 post treatment.
The treatment is: Vialebex 20% 100ml every 8 hours during 3 days versus saline 100ml every 8 hours during 3 days.
The first patient will be in July 2006, the last patient expected is on July 2009.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old
- •Septic shock < 6 hours
- •Agreement of patients
排除标准
- •Allergy to albumin
- •Weight > 120 kg
- •Non septic shock
- •Cirrhosis
- •Albumin perfusion 48 hours before randomization
- •Pregnant women
- •Cardiac dysfunction New York Heart Association (NYHA) 3 or 4
- •Patients with therapeutic limitation
研究组 & 干预措施
Albumin
干预措施: albumin (Drug)
Saline
干预措施: saline (Drug)
结局指标
主要结局
Mortality, any cause, during the 28 day period after randomization
时间窗: day 28
次要结局
- Evaluation of sequential organ failure assessment (SOFA) score(ICU period)
- catecholamine free days(day 28)
- incidence of nosocomial infection(ICU period)
- mortality at 90 days(day 90)
- length of ICU hospitalisation(ICU discharge)
- length of total hospitalisation(hospital discharge)