REmote Ischemic COnditioning in Out-of-Hospital Cardiac Arrest: The RECO-OHCA Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 28
- 主要终点
- Multiple organ failure
研究概览
简要总结
Out-of-Hospital Cardiac Arrest remains a major public health problem, resulting in high mortality largely related to multiple organ failure and poor neurological outcomes due to brain anoxia. The pathophysiology of organ dysfunction after resuscitated out-of-hospital cardiac arrest involves ischemia-reperfusion processes. Remote ischemic conditioning is a therapeutic strategy used to protect organs against the detrimental effects of ischemia-reperfusion injury.
The objective of the present trial is to determine whether remote ischemic conditioning performed early after out-of-hospital cardiac arrest can decrease mortality, or multiple organ failure and/or severe neurological failure.
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
- Single (Participant)
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
- •Age between 18 and 80 years old
- •Out-of-hospital cardiac arrest, whatever the initial cardiac rhythm (shockable or non-shockable) or the duration of no-flow and low-flow,
- •Presence of a witness who may or may not have started cardiopulmonary resuscitation, or patient seen alive in the 30 minutes prior to the cardiac arrest,
- •Hospitalisation in critical care (intensive care unit or cardiac intensive care unit) for less than 3 hours,
- •Informed consent obtained from a close relative (exceptionally from the patient himself if his condition permits) or, failing this, use of the emergency procedure by the investigator.
排除标准
- •Traumatic cardiac arrest
- •Patient on extracorporeal circulatory assistance
- •Cardiac arrest for which continuation of resuscitation does not appear justified (unavoidable death, terminal stage of an irreversible disease, etc.)
- •Contraindication of the use of brachial cuff on both arms (arteriovenous fistula, lymphoedema or severe peripheral vascular pathology, unstable humeral fracture, continuous infusion into an upper limb vein of an essential drug such as a catecholamine, radial arterial catheter for continuous invasive measurement of blood pressure)
- •Pregnant, parturient, or breast-feeding women
- •Patients deprived of their liberty by a judicial or administrative decision,
- •Patients under legal protection (guardianship, curatorship),
- •Patient not affiliated to a social security scheme or beneficiary of a similar scheme,
- •Previous inclusion in the study,
- •Subject participating in other interventional research that may interfere with the present study according to the investigator's judgement or that includes an exclusion period still in progress at inclusion
结局指标
主要结局
Multiple organ failure
时间窗: 72 hours after hospital admission
Multiple organ failure is defined by a SOFA (Sepsis-related Organ Failure Assessment) score, censored for the neurological component, greater than or equal to 5.
Severe neurological failure
时间窗: 72 hours after hospital admission
Severe neurological failure is defined by a motor component of the Glasgow Coma Score less than or equal to 3, without confounding factors (hypothermia less than or equal to 35.0°C, and/or sedation/analgesia/curarization). The glasgow coma score ranges from 3 to 15 and is broken down into its three parameters: eye opening, verbal response and motor response. The higher the score, the better the patient's recovery.
All cause of death
时间窗: 72 hours after hospital admission
All-cause death will be assessed 72 hours after hospital admission.
次要结局
- Serum level of neuron-specific enolase (NSE)(Between 48 and 72 hours after hospital admission)
- Mean Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score(From hospital admission to 72 hours (or from hospital admission to death if it occurs before 72 hours))
- Variations of the Sepsis-related Organ Failure Assessment (SOFA) score (delta-SOFA) after exclusion of the neurological sub-score(Between hospital admission to 24 hours, admission to 48 hours and admission to 72 hours)
- Sepsis-related Organ Failure Assessment (SOFA) score(72 hours after hospital admission)
- Sepsis-related Organ Failure Assessment (SOFA) sub-scores for each organ dysfunction(72 hours after hospital admission)
- Sepsis-related Organ Failure Assessment (SOFA) score after exclusion of the neurological sub-score(72 hours after hospital admission)
- Mean Sepsis-related Organ Failure Assessment (SOFA) score(From hospital admission to 72 hours (or from hospital admission to death if it occurs before 72 hours))
- Variations of the Sepsis-related Organ Failure Assessment (SOFA) score (delta-SOFA)(Between hospital admission to 24 hours, admission to 48 hours and admission to 72 hours)
- All-cause mortality(From date of randomization until day 90 after hospital admission)
- Cerebral Performance Categories (CPC) scale(Day 90)