跳至主要内容
临床试验/NCT03345706
NCT03345706Unknown不适用

To Evaluate the Feasibility and Safety of Selective Cerebral Hypothermia in Out-of-hospital Cardiac Arrest (OHCA) Patients Receiving ECPR.

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年10月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
The feasibility and safety of selective cerebral hypothermia in out-of-hospital cardiac arrest (OHCA) patients receiving ECPR.

研究概览

简要总结

The study is designed as a pilot, open-label study to investigate the feasibility and safety of selective cerebral hypothermia in OHCA patients receiving ECPR.

详细描述

Patients with OHCA and meeting the criteria for initiating extracorporeal membrane oxygenation (ECMO) criteria will be checked for eligibility for the study during CPR by the emergency physicians or staff at the scene. Informed consent will be asked as well. The standard V-A circuit for ECMO will be applied to the patients as soon as they arriving ER following the standard operation procedure of the hospital. The necessary testing and procedures will be applied to check the eligibility of the patients. Eligible subjects and/or their legal representatives will be further confirmed for the consent of experimental selective cerebral hypothermia. Systemic hypothermia at 33.5+/-0.5°C (33-34°C) for 48 hours will be performed to all eligible subjects.

For subjects who consent to receive selective cerebral hypothermia, they will be transferred to the catheterization lab for the blood flow controlling and cooling system settlement. Subjects then will be transferred to ICU for the 12-hour selective cerebral hypothermia procedure. Cooling will be initiated and targeted to reach ipsilateral nasal temperature of 27+/-2°C for 12 hours, followed by controlled rewarming. Both ipsilateral and contralateral nasal temperature will be monitored throughout. Activated clotting time (ACT) monitoring should be performed every 2 hours till stable and then every 12 hours during the whole cooling procedure. Also, subjects will receive systemic hypothermia via ECMO at 33.5+/-0.5°C (33-34°C) for 48 hours at the same time.

Subjects will stay and be observed in ICU until subject's condition is stable and can be transferred to general ward by investigator's judgment. The weaning of ECMO will be judged by investigator based on the subject's condition.

For subjects who do not agree to receive selective cerebral hypothermia, only the systemic hypothermia via ECMO will be applied. Subjects will receive systemic hypothermia at 33.5+/-0.5°C (33-34°C) for 48 hours via ECMO following the standard operative procedure.

Subject weaned from ECMO will be transferred to ward and will be followed until 6 months after the event. Outcome improvement and safety will be evaluated following scheduled timeline.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Selective cerebral hypothermia

Experimental

Selective cerebral hypothermia

干预措施: Selective cerebral hypothermia (Procedure)

Regular hypothermia

Active Comparator

Regular hypothermia

干预措施: Regular hypothermia (Procedure)

结局指标

主要结局

The feasibility and safety of selective cerebral hypothermia in out-of-hospital cardiac arrest (OHCA) patients receiving ECPR.

时间窗: 12 hours

The laboratory tests( CBC, liver function, kidney function, electrolytes,coagulation) . The percentage of subjects who have clinically-significant abnormal findings will be summarized by individual assessments of each category.

次要结局

  • The outcome of selective cerebral hypothermia in OHCA patients receiving ECPR.(6 Month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验