AMCPR (Augmented-Medication CardioPulmonary Resuscitation) for Improving Outcome in Patient With Cardiac Arrest: Multi-center, Double-blind, Prospective Randomized Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Sustained return of spontaneous circulation (ROSC)
研究概览
简要总结
The investigators aimed to evaluate the effect of AMCPR (Augmented-Medication CardioPulmonary Resuscitation: administration of additional vasopressin to titrate to arterial diastolic blood pressure over 20 mmHg) on cardiopulmonary resuscitation results and outcomes in out-of-hospital cardiac arrest patients.
详细描述
Non-traumatic out-of-hospital cardiac arrest patients receive standard advanced cardiac life support according to the 2015 AHA guideline, including chest compression, intubation, ventilation, defibrillation, drug administration, including epinephrine and antiarrhythmic drugs if indicated, in the emergency department.
A research associate generates a random sequence using Excel software, and assignment of participants to their respective groups will be undertaken by the principal investigator.
Arterial line insertion is performed within 6 minutes after randomization and diastolic blood pressure will be monitored.
If diastolic blood pressure is < 20 mmHg, drugs (vasopressin 40 IU or normal saline) will be administered for two times during CPR.
Arterial blood gas analysis will be analyzed for 5, 10, 15, and 20 minutes after arterial line insertion or termination of CPR.
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
- Triple (Participant, Care Provider, Investigator)
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
- •non-traumatic adult out-of-hospital cardiac arrest (OHCA) patients with non-shockable arrest rhythm
排除标准
- •OHCA with terminal illness documented by medical record, under hospice care, with pregnancy, with pre-documented 'Do Not Resuscitate' card
- •trauma patients
- •age < 18 years old
- •failed arterial line insertion within 6 minutes after randomization
- •Extracorporeal cardiopulmonary resuscitation
- •Time interval between arrest and ED arrival > 60 minutes
- •ROSC within 6 minutes after ED arrival
- •Diastolic Blood Pressure > 20 mmHg during resuscitation
研究组 & 干预措施
Vasopressins
Additional vasopressin 40 IU intravenous injection for 2 times
干预措施: Vasopressins (Drug)
Normal saline
Additional normal saline intravenous injection for 2 times
干预措施: Normal saline (Drug)
结局指标
主要结局
Sustained return of spontaneous circulation (ROSC)
时间窗: for 20 minutes after the time that participants had a palpable pulse
CPCR result Achievement of sustained ROSC was declared when patients had a palpable pulse for more than 20 minutes.
次要结局
- Improvement of arterial diastolic blood pressure assessed by arterial line(during CPR, every 10 seconds after arterial line insertion until the termination of CPR due to ROSC or death, whichever came first, assessed up to 30 minutes)
- Improvement of lactate level measured by blood-gas analysis(during CPR, 5, 10, 15, and 20 minute after arterial line insertion and termination of CPR)
- Improvement of acid-base status measured by blood-gas analysis(during CPR, 5, 10, 15, and 20 minute after arterial line insertion and termination of CPR)
- Low level of neuron specific enolase level(24, 48, and 72 hours after ROSC)
- Improvement of end-tidal carbon dioxide concentrations assessed by capnography(during CPR, every one minute after endotracheal tube insertion until the termination of CPR due to ROSC or death, whichever came first, assessed up to 30 minutes)
- Good neurological outcome based on Cerebral Performance Categories Scale(checked at hospital discharge (participants will be followed for duration of hospital stay, an expected average of 4 weeks))
研究者
Won Young Kim
Professor
Asan Medical Center