Fixed-schedule Benzodiazepine Dosing vs Based on a CIWA-Ar Alcohol Protocol in Alcohol Detoxification.

Completed

• Conditions: CIWA-R; Benzodiazepines; Alcoholdependence
• Interventions: Other: diazepam (or equivalence if other benzodiazepine)

• Registration Number: NCT04777552
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

Does the use of a symptom-triggered therapy (with assessment making use of a CIWA-Ar scale) decrease the total amount of benzodiazepines given to patients with alcohol dependence and are less patients still dependent on benzodiazepines on their departure in comparison with the use of a fixed-schedule dose of benzodiazepines?

Detailed Description

Methodology This study will be a retrospective study using administrative and clinical patient data of patients presenting for alcohol detoxification at the Psychiatry department of the Universitair Ziekenhuis Brussel. Two periods in the data will be compared. One period will be consisting of patient data before 2013 when the hospital still used the fixed-schedule dosing of benzodiazepines. The other period will be consisting of patient data after 2013 when the hospital switched to the symptom-triggered prescription of benzodiazepines.

Inclusion \& Exclusion criteria Inclusion criteria are patients with the age of 18 years or older who were treated for alcohol .dependence at the UZ Brussel in one of the periods stated above. The criteria for exclusion were found in the literature and include pregnancy, use of central nervous system (CNS) depressant agents, history of dementia, acute psychosis, and severe hepatic dysfunction (15-18). Comorbid benzodiazepine dependence. A history of severe epilepsy on withdrawal,... Outcomes The main outcome measures will be the total amount of benzodiazepines given during the hospital stay, whether the patient is still dependent on benzodiazepines when leaving the hospital, the length of the hospital stay, and some baseline patient characteristics. These patient characteristics will include age, sex, race/ethnic group, primary reason for hospitalization, body mass index (BMI), blood alcohol level (BAL) on admission, international normalized ratio (INR), diagnosis of co-morbid psychiatric disorder, history of other substance abuse, indicators of withdrawal severity (e.g. CIWA-Ar, tremor, seizures), discharge medications, benzodiazepine dose administered (15-18).

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-12-09
• Primary Completion: 2016-04
• Study Completion: 2016-05
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-25
• Last Update Submitted: 2021-02-25
• Study First Posted: 2021-03-02
• Last Update Posted: 2021-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

pregnancy, use of central nervous system (CNS) depressant agents, history of dementia, acute psychosis, and severe hepatic dysfunction. Comorbid benzodiazepine dependence. A history of severe epilepsy on withdrawal,...

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fixed-schedule	diazepam (or equivalence if other benzodiazepine)	Untill mid 2013 patients with individually determined fixed-schedule dosage of benzodiazepines in the case of alcoholdependence.
CIWA-Ar	diazepam (or equivalence if other benzodiazepine)	Halfway through the year 2013 the department of psychiatry changed the protocol in alcohol withdrawal treatment and changed it to a symptom-triggered therapy with the use of CIWA-Ar to assess the severity of the alcohol withdrawal syndrome.

Primary Outcome Measures

Name	Time	Method
total amount of benzodiazepines administrated	7 days