Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04777552
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2015-12-09
Brief Title:
Fixed-schedule Benzodiazepine Dosing vs Based on a CIWA-Ar Alcohol Protocol in Alcohol Detoxification
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Universitair Ziekenhuis Brussel
Study Overview
Official Title:
The Use of Fixed-schedule Benzodiazepine Dosing Versus Treatment Based on a CIWA-Ar Alcohol Protocol in Alcohol Detoxification
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 raceethnic 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 eg CIWA-Ar tremor seizures discharge medications benzodiazepine dose administered 15-18
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 raceethnic 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 eg CIWA-Ar tremor seizures discharge medications benzodiazepine dose administered 15-18
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None