Protocolized Initiation of Clonidine to Prevent Dexmedetomidine Withdrawal: A Prospective Cohort Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Number of Participants With Withdrawal
研究概览
简要总结
The purpose of this study is to determine if the protocolized use of clonidine will reduce dexmedetomidine withdrawal symptoms, reduce PICU length of stay, and reduce costs related to sedation during hospital admission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Weeks 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dexmedetomidine infusion for greater than or equal to 72 hours
排除标准
- •Admission for head trauma
- •Psychiatric history
- •Use of alpha-2 agonist medications at home
- •Death while on dexmedetomidine
研究组 & 干预措施
Usual care (without protocolized clonidine initiation)
Participants will be observed for dexmedetomidine withdrawal and clonidine will be started at clinician discretion.
干预措施: Clonidine (without protocolized initiation) (Drug)
Intervention (protocolized clonidine initiation)
A protocol for clonidine initiation will be implemented based on the time on dexmedetomidine and the average hourly dose of dexmedetomidine.
干预措施: Clonidine (protocolized initiation) (Drug)
结局指标
主要结局
Number of Participants With Withdrawal
时间窗: from the time dexmedetomidine is first weaned until 72 hours after dexmedetomidine is off (about 3-14 days)
The number of participants with withdrawal is reported. Withdrawal is defined as: (increase in heart rate, systolic blood pressure, and/or diastolic blood pressure by at least 10% from the 24 hours prior to dexmedetomidine weaning to the 24 hours after dexmedetomidine is discontinued) AND (two documented WAT (Withdrawal assessment tool)-1 scores of ≥ 3 and/or two study questionnaire scores of ≥ 3). WAT and questionnaire scores will be collected every 12 hours starting with the first dexmedetomidine wean until 72 hours after dexmedetomidine is discontinued. WAT-1 is a scoring tool used to evaluate symptoms of withdrawal with a total score that ranges from 0 to 12. The higher the score the more severe the withdrawal. The study questionnaire is used to evaluate degree of agitation and/or insomnia with a total score that ranges from 0 to 7, a higher score indicates higher degrees of agitation and/or insomnia.
次要结局
- Hours on Dexmedetomidine(During time in Pediatric Intensive Care Unit (about 260 Hours))
- Pediatric Intensive Care Unit (PICU) Length of Stay(During time in Pediatric Intensive Care Unit (about 10 to 30 days))
- Dexmedetomidine Cost Per Kilogram During Hospitalization(During time in Pediatric Intensive Care Unit (about 24 days))
- Clonidine Cost Per Kilogram During Hospitalization(During time in Pediatric Intensive Care Unit (about 24 days))
研究者
Andrea Leigh Heifner
Clinical Fellow
The University of Texas Health Science Center, Houston