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

NCT02496650 | Completed Phase 4

• 1 other identifier: 234
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

alcohol withdrawal state; dexmedetomidine; benzodiasepines; intensive care

Outcome Measures

Primary Outcomes (2)

• 24-hour diazepam consumption

  24-hour diazepam consumption was estimated after the study begins.

  24 hours

• Cumulative diazepam dose

  Diazepam dose required over the course of ICU stay

  30 days

Secondary Outcomes (5)

• Length of ICU stay

  30 days

• the time of target sedation

  24 hours

• the number of rescue sedation boluses

  24 hours

• the number of sedation stops

  24 hours

• Adverse events

  30 days

Study Arms (2)

Group D

EXPERIMENTAL

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.

Drug: Dexmedetomidine

Group C

NO INTERVENTION

Benzodiasepine (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 for severe agitation or hallucinations.

Interventions

Dexmedetomidine DRUG

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

Also known as: Dexdor

Group D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bogomolets National Medical University: lead

Related Publications (1)

• Bielka K, Kuchyn I, Glumcher F. Addition of dexmedetomidine to benzodiazepines for patients with alcohol withdrawal syndrome in the intensive care unit: a randomized controlled study. Ann Intensive Care. 2015 Dec;5(1):33. doi: 10.1186/s13613-015-0075-7. Epub 2015 Nov 2.

  PMID: 26525052 DERIVED

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, clinical resident

Study Record Dates

• First Submitted: July 10, 2015
• First Posted: July 14, 2015
• Study Start: January 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 14, 2015

Record last verified: 2015-07