Amantadine to Speed Awakening After Cardiac Arrest
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- Rate of Awakening (Number of Patients Who Are Able to Follow Commands)
研究概览
简要总结
This study evaluates if amantadine will increase the rate of awakening in patients resuscitated from cardiac arrest but comatose (not following commands) after their resuscitation. Half of the participants will receive amantadine and the other will receive placebo.
详细描述
Amantadine has been used to help patients awaken following traumatic brain injury, but it has not been studied in patients with anoxic brain injury.
Amantadine is a dopamine agonist and may help with stimulating the brain to awaken. The investigators will randomize subjects who remain comatose 72 hours following resuscitation from cardiac arrest to either amantadine or placebo. They will be treated with either amantadine or placebo for 7 days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 cardiac arrest
- •Age 18 and older
- •Defibrillation and/or chest compressions by healthcare providers
- •Return of spontaneous circulation
排除标准
- •Written do not attempt resuscitation (DNAR) reported to providers before randomization
- •Known prisoner or pregnancy
- •Lack of motor response to pain and absent N20 response on somatosensory evoked potentials prior to randomization
- •Initial CT demonstrating brain edema (defined as grey white ratio <1.2)
- •Presence of malignant pattern on EEG at time of randomization
- •Next of kin unwilling to provide supportive care for at least one week after enrollment
- •Presently using other dopaminergic agent
研究组 & 干预措施
Placebo
Placebo medication administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
干预措施: Placebo (Drug)
Amantadine
100mg Amantadine administered at 0600 and 1200 via mouth, gastric tube or duo-tube.
干预措施: Amantadine (Drug)
结局指标
主要结局
Rate of Awakening (Number of Patients Who Are Able to Follow Commands)
时间窗: up to 28 days
Defined as the ability to follow commands (i.e. "wiggle your toes" "open your eyes" "squeeze my fingers". This corresponds to a Full Outline of Unresponsiveness motor score of 4. FOUR (full outline of unresponsiveness) measures the following: Eye Response, Motor Response, Brainstem Reflexes, and Respirations.
次要结局
- Nausea or Vomiting(during study drug administration (7 days))
- Time to Awakening(up to 28 days)
- Seizures (Number of Patients Who Experience Seizures as Detected by EEG Monitoring With or Without Clinical Correlate)(during study drug administration (7 days))
- Number of Participants With Severe or Intracranial Bleeding(28 days)
研究者
Jon Rittenberger, MD
Associate Professor of Emergency Medicine
University of Pittsburgh