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

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Completed
CT.gov ID
NCT04777552
Collaborator
(none)
50
7

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Other: diazepam (or equivalence if other benzodiazepine)

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 Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
The Use of Fixed-schedule Benzodiazepine Dosing Versus Treatment Based on a CIWA-Ar Alcohol Protocol in Alcohol Detoxification.
Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Fixed-schedule

Untill mid 2013 patients with individually determined fixed-schedule dosage of benzodiazepines in the case of alcoholdependence.

Other: diazepam (or equivalence if other benzodiazepine)

CIWA-Ar

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.

Other: diazepam (or equivalence if other benzodiazepine)

Outcome Measures

Primary Outcome Measures

  1. total amount of benzodiazepines administrated [7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion Criteria

  • patients who were treated for alcohol dependence at the UZ Brussel in one of the periods stated above.
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,…

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Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universitair Ziekenhuis Brussel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dieter Zeeuws, MD Resident Psychiatry, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT04777552
Other Study ID Numbers:
  • 2015/298
First Posted:
Mar 2, 2021
Last Update Posted:
Mar 2, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2021