Remote Ischemic Postconditioning in Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 720
- 试验地点
- 46
- 主要终点
- All-cause mortality at day 90 after inclusion
研究概览
简要总结
Septic shock is a leading cause of death worldwide despite intensive research efforts. Only a few interventions have been proven to be effective in improving patient-centered outcomes. Recent clinical trials have reported the safety and efficacy of remote ischemic postconditioning (RIPOST) in a variety of pathologies, including myocardial infarction, cardiac surgery, and stroke. While RIPOST was mainly tested in pathologies with low mortality rates, several follow-up studies of large randomized clinical trials in acute myocardial infarction and in patients undergoing coronary artery bypass surgery have reported significant decreases (> 50%) in long-term mortality. Experimental studies and proof-of-concept clinical trials have also suggested the potential benefits of RIPOST on mortality in sepsis and septic shock. The present protocol aims to test whether this non-invasive, widely available, inexpensive, and innovative intervention can improve survival in septic shock.
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 (Participant)
盲法说明
In the control group, no intervention is performed.
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
- •Age ≥ 18 years
- •Hospitalized in intensive care unit for less than 24 hours
- •Septic shock (Sepsis-3 definition) evolving for less than 18 hours
- •Preliminary written informed consent obtained from the patient or his/her close relative, or use of the emergency procedure in accordance with local regulations
排除标准
- •Contraindication of the use of a brachial pressure cuff on both arms
- •Cardiac arrest
- •Pregnancy or breast feeding
- •Participation in another interventional study
- •Lack of French national health insurance coverage
- •Patient with any legal protection measure
研究组 & 干预措施
Remote ischemic conditioning
A brachial cuff is positioned around one arm of the patient. Remote ischemic conditioning consists of alternating inflations and deflations of the brachial cuff. Four cycles of ischemic conditioning (5-min brachial cuff inflation at 200 mmHg followed by 5-min cuff deflation) are started as soon as possible after inclusion. The intervention is repeated 12 and 24 hours after inclusion.
干预措施: Remote ischemic conditioning (Other)
Control group
No intervention wil be performed in the control group.
干预措施: No intervention (Other)
结局指标
主要结局
All-cause mortality at day 90 after inclusion
时间窗: 90 days after inclusion
次要结局
- Functional recovery(Day 90)
- SF-36 (Short Form-36 Health Survey) questionnaire score(Day 90)
- Number of days alive without vasopressors(Day 7)
- Sepsis-induced immuno-inflammatory responses(Inclusion and days 1, 3 and 7)
- Sepsis-related Organ Failure Assessment (SOFA) score(Inclusion and days 1, 3 and 7)