REmote Ischemic COnditioning in Septic Shock: The RECO-Sepsis Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 11
- 主要终点
- Average SOFA score (Sequential Organ Failure Assessment)
研究概览
简要总结
Septic shock remains a major public health problem in industrialized countries, with a mortality rate as high as 50%, largely related to multiple organ dysfunction. In addition to dysregulated inflammatory response, the pathophysiology of organ failures in septic shock involves ischemia-reperfusion processes. Remote ischemic conditioning is a therapeutic strategy for protecting organs against the detrimental effects of ischemia-reperfusion injury.
The objective of the present study is to determine whether remote ischemic conditioning can limit the severity of organ failure in patients with 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
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
- •Hospitalization in an intensive care unit for less than 24 hours
- •Septic shock evolving for less than 12 hours defined as:
- •Documented or suspected infection
- •Norepinephrine administration to maintain a mean arterial pressure ≥ 65 mmHg after volemia correction
- •Lactatemia > 2 mmol/L at least once in the past 12 hours before inclusion
- •Written informed consent signed by the patient or by a next of kin or oral consent given by the patient and as soon as permitted by the clinical state written informed consent signed by the patient.
排除标准
- •Patient who has expressed the wish not to be resuscitated
- •Contraindication of the use of brachial cuff on both arms
- •Intercurrent pathology with an expected life expectancy of less than 24 hours
- •Cardiac arrest
- •Female patients currently pregnant or women of childbearing age who are not using contraception
- •Previous inclusion in RECO-Sepsis study
- •Previous inclusion in another clinical study
- •Patients without health coverage
结局指标
主要结局
Average SOFA score (Sequential Organ Failure Assessment)
时间窗: 96 hours.
The SOFA score ranges from 0 to 24 (higher scores indicate more severe organ failure), with 0 to 4 points assigned for each of 6 organ dysfunctions (ie, central nervous system, cardiovascular, respiratory, renal, coagulation, and liver).
次要结局
- Hospital length of stay(Day 90)
- All-cause mortality(Day 90)
- Average SOFA score without the neurologic sub-score.(96 hours.)
- SOFA score.(96 hours)
- Variations of SOFA score (delta-SOFA)(24 hours)
- SOFA sub-scores for each organs(96 hours)
- Survival without organ support(Day 28)
- Intensive care unit (ICU) length of stay.(Day 90)