Dexmedetomidine Addition to Benzodiazepines for Patients With Alcohol Withdrawal Syndrome in the ICU: a Randomised Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- 24-hour diazepam consumption
研究概览
简要总结
The objective of this randomized controlled study was to evaluate whether DEX addition to benzodiazepine therapy is effective and safe for AWS patients in the intensive care unit (ICU). Eligible participants were randomly assigned to intervention (D) and control (C) groups. In the group D DEX infusion was started in doses 0,2-1,4 μg/kg/hr and titrated to achieve target sedation level; symptom-triggered BZD administration (diazepam 10mg bolus) were used wherever DEX infusion was not enough. In group K BZD boluses (diazepam 10mg) were used to achieve target sedation level and to control AWS symptoms (symptom-triggered administration). The primary efficacy outcomes were 24-hour diazepam consumption and cumulative diazepam dose required over the course of ICU stay, secondary outcomes were length of ICU stay, sedation and communication quality, haloperidol consumption.
详细描述
Ethical issues This study was approved by the Bogomolets National Medical University ethics committee and a written informed concern was obtained from the patient, the patient's family or a legal representative.
Study design This randomized, single-center, controlled study was conducted in the adult ICU at private hospital "Boris" in Kiyv (Ukraine). The inclusion criteria were: age 18 or older, signed informed concern, within 2 hours of ICU admission, diagnosed alcohol withdrawal syndrome or alcohol withdrawal delirium by DSM IV criteria (). The exclusion criteria were age younger than 18 or older than 75, history of use or withdrawal states of other psychoactive substances, general anesthesia during last 24 hours or known other sedatives use, severe neurologic disorder (traumatic brain injury, acute stroke, severe dementia), pregnancy or lactation, severe comorbidities (severe heart failure, acute myocardial infarction, heart rate <50/min, glomerular filtration rate < 30 ml/min, liver failure Child-Pugh class C), known allergy to the study medication.
After primary patient assessment the target sedation level was set individually and study treatment begun. Eligible participants were randomly assigned in a 1:1 ratio to the intervention (group D) and control groups using random assignment in block of four. In group D DEX infusion was started in doses 0,2-1,4 μg/kg/hr and titrated to achieve target sedation level; symptom-triggered BZD administration (diazepam 10mg bolus) were used wherever DEX infusion was not enough. In group K BZD boluses (diazepam 10mg) were used to achieve target sedation level and to control AWS symptoms (symptom-triggered administration). Antipsychotics (haloperidol 5mg boluses) were used as a rescue medication in both groups for severe agitation or hallucinations.
Study outcomes and statistical analysis The primary efficacy outcomes were 24-hour diazepam consumption after study begins and cumulative diazepam dose required over the course of ICU stay.
The secondary efficacy outcomes include:
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 or older,
- •signed informed concern,
- •within 2 hours of ICU admission,
- •diagnosed alcohol withdrawal syndrome or alcohol withdrawal delirium by DSM IV criteria
排除标准
- •younger than 18 or older than 75,
- •history of use or withdrawal states of other psychoactive substances,
- •general anesthesia during last 24 hours or known other sedatives use,
- •severe neurologic disorder (traumatic brain injury, acute stroke, severe dementia),
- •pregnancy or lactation,
- •severe comorbidities (severe heart failure, acute myocardial infarction, heart rate <50/min, glomerular filtration rate < 30 ml/min, liver failure Child-Pugh class C),
- •known allergy to the study medication.
研究组 & 干预措施
Group D
Dexmedetomidine (DEX) infusion was started in doses 0,2-1,4 μg/kg/hr and titrated to achieve target sedation level; symptom-triggered BZD administration (diazepam 10mg bolus) were used wherever DEX infusion was not enough. Antipsychotics (haloperidol 5mg boluses) were used as a rescue medication for severe agitation or hallucinations.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
24-hour diazepam consumption
时间窗: 24 hours
24-hour diazepam consumption was estimated after the study begins.
Cumulative diazepam dose
时间窗: 30 days
Diazepam dose required over the course of ICU stay
次要结局
- the number of sedation stops(24 hours)
- Adverse events(30 days)
- Length of ICU stay(30 days)
- the time of target sedation(24 hours)
- the number of rescue sedation boluses(24 hours)
研究者
Kateryna Bielka
Medical doctor, clinical resident
Bogomolets National Medical University