Remote Ischemic Conditioning to Enhance Resuscitation (RICE) Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Attrition
研究概览
简要总结
Following resuscitation from out-of-hospital cardiac arrest (OHCA), reperfusion injury can cause cell damage in the heart and brain. Remote ischemic conditioning (RIC) consists of intermittent application of a device such as a blood pressure cuff to a limb to induce non-lethal ischemia. Studies in animals with cardiac arrest as well as in humans with acute myocardial infarction suggest that RIC before or after restoration of blood flow may reduce injury to the heart and improve outcomes but this has not been proven in humans who have had OHCA. The RICE pilot study is a single-center study to assess the feasibility of application of RIC in the emergency department setting for patients transported to the hospital after resuscitation from OHCA.
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
- Double (Participant, Investigator)
盲法说明
Patients and investigators will be masked to treatment assignment up to the point of randomization.
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
- •Included will be those with:
- •Age 18 years or more;
- •Defibrillation by laypersons or defibrillation and/or chest compressions by EMS providers dispatched to the scene;
- •Non-traumatic etiology of arrest, defined as without concomitant blunt, penetrating, or burn-related injury, or uncontrolled bleeding or exsanguination;
- •Spontaneous circulation upon emergency department arrival;
- •No response to verbal commands; and
- •Ongoing or planned induced hypothermia.
- •Excluded will be those with:
- •STEMI indicated on first 12-lead ECG obtained after restoration of circulation, defined as ST-elevation of ≥2 mm in two or more contiguous ECG leads;
- •Written do not attempt resuscitation (DNAR) reported to providers before randomization;
- •Drowning or hypothermia as cause of arrest;
- •Known prisoner or pregnant; or
- •Dialysis fistula in either upper extremity; or
- •Pre-existing amputation of upper extremity.
排除标准
- 未提供
研究组 & 干预措施
Intervention Group
A standard non-invasive blood pressure cuff (e.g., American Diagnostics Corporation, Hauppauge, NY but any one can be used off the shelf) and disposable plastic clamp (e.g.,Medline Industries Incorporated, Mundelein, IL) can be used to apply RIC in patients resuscitated from OHCA via three cycles of 5-mins. inflation to 200 mmHg followed by 5-mins. deflation of a blood pressure cuff on an upper extremity. The cuff occludes the artery; the clamp maintains pressure in the air bladder of the cuff during the inflation periods.
干预措施: Active Remote Ischemic Conditioning (Device)
Control Group
The control group will have a sham package opened at the bedside as soon as feasible after ED arrival. This will be identical in size, weight and appearance as that in the intervention group, but will contain a sham device. Upon identification that the patient has been randomized to the control group, the care team will proceed with all other resuscitative measures as in the the intervention group.
干预措施: Sham Remote Ischemic Conditioning (Device)
结局指标
主要结局
Attrition
时间窗: Completion of their allocated study intervention, an average of 30 minutes from enrollment
Attrition assessed as the proportion of randomized subjects who do not remain on allocated therapy for the intended study duration among subjects randomly allocated. On therapy for the intended study duration consists of completing three cycles of inflation-deflation.
次要结局
- Myocardial Injury(Within 24 hours of index arrest)
- Treatment Success(30 minutes from initiation of study intervention)
- Cardiac Function(Within 48 hours of index arrest)
- Proportion With Cardiogenic Shock, %(Within 48 hours of index arrest)
- STEMI(Within 48 hours of index arrest)
- Renal Dysfunction(Within 24 hours of index arrest)
- Hospital Free Survival(Within 30 days of index arrest)
- Withdrawal of Care(Discharge or 30 days after index arrest)
- Favourable Neurologic Status at Discharge(Discharge or 30 days after index arrest)
- Survival to Discharge(Discharge or 30 days after index arrest)
- Clinical Instability at Discharge(Discharge or 30 days after index arrest)
- Survival to 30 Days After Arrest(30 days after index arrest)
- Accrual(Before leaving the emergency department)
研究者
Graham Nichol
Professor, School of Medicine: Department of Medicine: General Internal Medicine
University of Washington