Pilot Community Clinical Study of Hypothermia in Cardiac Arrest
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 125
- 主要终点
- Temperature difference between first field temperature and hospital arrival temperature
研究概览
简要总结
The overall goal of this study is to determine the feasibility of initiating hypothermia in cardiac arrest patients as soon as possible in the field. In this pilot study we will randomize 125 patients after return of spontaneous circulation (ROSC) to hypothermia with rapid infusion of 2 liters of 4oC Normal Saline IV solution over 20 to 30 minutes, IV sedation and muscle paralysis or to standard of care following ROSC. The primary objectives of this study will be to determine whether temperature of 33-34oC can be achieved and maintained using this strategy. The primary outcome measures will include: temperature changes of the patients at time of admission to the hospital. Secondary analysis will include determining if the proportion of patients discharged from the hospital is increased in the group receiving hypothermia. If this initial pilot study can demonstrate feasibility in achieving and maintaining hypothermia, a larger randomized clinical trial to test the hypothesis that hypothermia initiation in the field will increase the proportion of patients surviving following cardiac arrest will be planned.
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
- •Resuscitated out-of-hospital cardiac arrest defined as having a palpable pulse comatose IV access Intubated
排除标准
- •age less than 18 traumatic cause of cardiac arrest
研究组 & 干预措施
Cold fluid
干预措施: Up to 2 liter infusion of cold 4 degree C normal saline (Drug)
结局指标
主要结局
Temperature difference between first field temperature and hospital arrival temperature
时间窗: less than 60 minutes
次要结局
- Survival to discharge from hospital(Between 2 -30 days)
- Awakening in the hospital(between 2-30 days)
研究者
Francis Kim
Associate Professor, Medicine, Division of Cardiology
University of Washington
