Dexmedetomidine Addition to Benzodiazepines for Patients With Alcohol Withdrawal State in the ICU

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bogomolets National Medical University
• Treatments: Dexmedetomidine; Ethanol

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.