drugset / Trial / NCT02496650

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

NCT02496650 ↗

Phase 4 Completed 70 enrolled Bogomolets National Medical University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2013-01
Primary completion
2015-01
Completion
2015-06

Outcome

Met primary endpoint

paper Median 24-h diazepam consumption during the study was significantly lower in Group D (20 vs. 40 mg, p < 0.001) PMID 26525052 ↗

paper median cumulative diazepam dose during the ICU stay (60 vs. 90 mg, p < 0.001). PMID 26525052 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 0.2 ug/kg Other
Subject Dexmedetomidine Other / unclassified 1.4 ug/kg Other

Indications