Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04777552 |
| Other study ID # |
2015/298 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2015 |
| Est. completion date |
May 2016 |
Study information
| Verified date |
February 2021 |
| Source |
Universitair Ziekenhuis Brussel |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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?
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).
