Early Albumin Resuscitation During Septic Shock
关键词
抽象
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.
日期
| 最后验证: | 03/31/2011 |
| 首次提交: | 05/16/2006 |
| 提交的预估入学人数: | 05/16/2006 |
| 首次发布: | 05/17/2006 |
| 上次提交的更新: | 04/04/2011 |
| 最近更新发布: | 04/05/2011 |
| 实际学习开始日期: | 06/30/2006 |
| 预计主要完成日期: | 05/31/2010 |
| 预计完成日期: | 12/31/2010 |
状况或疾病
干预/治疗
Drug: Albumin
Drug: Saline
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Albumin | Drug: Albumin albumin 20% 100 ml/8 hours for 3 days |
| Placebo Comparator: Saline | Drug: Saline saline 100 ml/8hours for 3 days |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Over 18 years old - Septic shock < 6 hours - Agreement of patients Exclusion Criteria: - Allergy to albumin - Weight > 120 kg - Non septic shock - Burned - Cirrhosis - Albumin perfusion 48 hours before randomization - Pregnant women - Cardiac dysfunction New York Heart Association (NYHA) 3 or 4 - Patients with therapeutic limitation |
结果
主要结果指标
1. Mortality, any cause, during the 28 day period after randomization [day 28]
次要成果指标
1. Evaluation of sequential organ failure assessment (SOFA) score [ICU period]
2. catecholamine free days [day 28]
3. incidence of nosocomial infection [ICU period]
4. mortality at 90 days [day 90]
5. length of ICU hospitalisation [ICU discharge]
6. length of total hospitalisation [hospital discharge]
