跳至主要内容
临床试验/NCT00329563
NCT00329563已完成1 期

Pilot Community Clinical Study of Hypothermia in Cardiac Arrest

University of Washington0 个研究点目标入组 125 人开始时间: 2004年11月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Francis Kim

Associate Professor, Medicine, Division of Cardiology

University of Washington

相似试验