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

NCT02496650 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2015-07-14

No results posted yet for this study

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.

Conditions

  • Alcohol Withdrawal State

Interventions

DRUG

Dexmedetomidine

DEX infusion in doses 0,2-1,4 μg/kg/hr

Sponsors & Collaborators

  • Bogomolets National Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-01-31
Completion
2015-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02496650 on ClinicalTrials.gov