Phenobarbital Versus Placebo for Acute Alcohol Withdrawal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Number of Patients Requiring Continuous Lorazepam Infusion
研究概览
简要总结
Intravenous phenobarbital in combination with a symptom-guided standardized lorazepam-based alcohol withdrawal protocol will be associated with decreased need for ICU admission, continuous lorazepam infusion and will not be associated with increased adverse events.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Need for admission to hospital for acute alcohol withdrawal
排除标准
- •allergy to phenobarbital, lorazepam, age<18 or >65
研究组 & 干预措施
Phenobarbital group
10 mg/kg IV phenobarbital in 100 ml saline
干预措施: 10 mg/kg IV phenobarbital in 100 ml saline (Drug)
Placebo group
100 ml saline
干预措施: placebo (Drug)
结局指标
主要结局
Number of Patients Requiring Continuous Lorazepam Infusion
时间窗: 1 year
All study patients are placed on the standardized institutional alcohol withdrawal protocol and receive boluses of lorazepam (1, 2 or 4 mg IV) based on their acute alcohol withdrawal score (AAWS), adminstered serially up to every 15 minutes. Patients who are refractory to the maximum dose of lorazepam allowed by the protocol (up to 4mg lorazepam IV q 15 mins)are placed on a continuous IV lorazepam infusion (or "lorazepam drip"). Thus, continuous lorazepam infusion is a "yes or no" variable (i.e. continuous infusion, or not).
Percentage of Patients Requiring ICU Admission
时间窗: 1 year
admission to intensive care unit
Total Lorazepam Required Per Patient Per Admission
时间窗: 1 year
How much total lorazepam did each study patient receive from inital presentation in the Emergency Department through their discharge from the hospital, in milligrams.
次要结局
- Length of Stay(1 year)
- Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability(1 year)
- Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability(1 year)
- Number of Study Patients With Seizure as a Measure of Safety and Tolerability(1 year)
- Number of Study Patients With Mortality as a Measure of Safety and Tolerability(1 year)
研究者
Jonathan Rosenson
Jonathan Rosenson MD
Alameda County Medical Center