A Randomized, Double-Blind, Placebo Controlled, Dose Escalation Study of Dexmedetomidine as Adjunctive Therapy for Alcohol Withdrawal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cumulative Lorazepam Dose Over the First Seven Days of Alcohol Withdrawal
研究概览
简要总结
This study is designed to evaluate dexmedetomidine as adjunctive therapy of severe alcohol withdrawal of medical ICU patients. Specifically, this study will assess whether adjunctive dexmedetomidine reduces the doses of conventional agents used for alcohol withdrawal while maintaining patient comfort and safety and will explore if dexmedetomidine exhibits a dose-dependent profile of action when it is used for this indication. In addition, this study will assess the relationships between alcohol withdrawal, therapy with dexmedetomidine, and potential serum biomarkers of alcohol withdrawal.
详细描述
The objectives of this randomized, double-blind, placebo controlled, dose escalation study are a) to determine if adding dexmedetomidine to symptom-triggered, standard therapy of severe alcohol withdrawal reduces the dose requirements of conventional sedatives, analgesics, and neuroleptics; maintains patient comfort and safety; and prevents and shortens tracheal intubation; b) to explore whether dexmedetomidine acts in a dose-dependent manner to reduce the dose requirements of conventional sedatives, analgesics, and neuroleptics while maintaining patient comfort; and c) determine the association between alcohol withdrawal and potential serum biomarkers of alcohol withdrawal and assess whether these are expressed differently when dexmedetomidine is used as adjunctive therapy. Dexmedetomidine will be added to existing sedative therapies in an effort to decrease the use of these agents while maintaining patient comfort. The study will randomize twenty-four patients in a double-blind manner to receive placebo or dexmedetomidine at doses of 0.4 or 1.2 µg/kg per hour for a maximum duration of five days. All patients will be managed using an existing institution-specific, symptom-triggered alcohol withdrawal protocol.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe alcohol withdrawal defined by a CIWA score ≥ 15 and the need for at least 16 mg of lorazepam over a four-hour period. All lorazepam doses, whether oral or intravenous, will contribute to the cumulative amount.
- •Patients receiving standard therapy for severe alcohol withdrawal according to a symptom-triggered alcohol withdrawal protocol. Lorazepam is the preferred benzodiazepine agent for patients requiring ICU admission due to alcohol withdrawal.
- •Informed consent within 36 hours of qualifying for the study.
排除标准
- •Patients < 18 years of age or > 85 years of age.
- •Patients receiving benzodiazepine therapy for purposes other than alcohol withdrawal (e.g. sedation).
- •Patients with alcohol withdrawal not requiring ICU admission.
- •Patients receiving epidural administration of medication(s).
- •Comatose patients by metabolic or neurologic affectation.
- •Patients with active myocardial ischemia or second- or third-degree heart block.
- •Moribund state with planned withdrawal of life support.
- •Patients with known or suspected severe adverse reactions to dexmedetomidine (or clonidine).
- •Pregnant females or females suspected of being pregnant
研究组 & 干预措施
Dexmedetomidine, low dose
Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine, high dose
Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days
干预措施: Dexmedetomidine (Drug)
Placebo
Normal saline
干预措施: Placebo (Other)
结局指标
主要结局
Cumulative Lorazepam Dose Over the First Seven Days of Alcohol Withdrawal
时间窗: Seven days
Change in 12-Hour Lorazepam Requirement Pre- and Post-Treatment
时间窗: 12 hours before treatment, 12 hours after treatment on first day of starting study drug
Change in 24-Hour Lorazepam Requirement Pre- and Post-Treatment
时间窗: 24 hours before treatment, 24 hours after treatment on first day of starting study drug
次要结局
- ICU Length of Stay(The duration of ICU stay in days as measured at time of hospital discharge, for up to 24 weeks)
- The Occurrence of Adverse Events.(Seven days)
- Duration of Study Drug Administration(The duration of study drug in hours as measured when the subject was discharged from the ICU, for up to 24 weeks)
- The Degree of Alcohol Withdrawal Assessed by Clinical Institute Withdrawal Assessment (CIWA) Scores(Every 2-4 hours for 24 hours after starting study drug)
- Plasma Epinephrine Concentrations Across Groups Over Time(Four days with samples measured prior to study drug and 48 and 96 hours after starting study drug)