Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04973202 |
Other study ID # |
RECHMPL21_0456 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 1, 2021 |
Est. completion date |
August 30, 2021 |
Study information
Verified date |
October 2021 |
Source |
University Hospital, Montpellier |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Even if hospital alcohol detoxifications are frequent in France, their
caracteristicscharacteristics remain unknown. The investigators aim to describe the clinical
and paraclinical caracteristicscharacteristics of their patients, their length and
geographical repartition, etc… The investigators also aim to evaluate factors associated with
longer stays or ulterior re-hospitalization for the same reason. Finally, The investigators
aim to compare the stays by facility type.
Description:
Context:
In France, the consequences of excessive alcohol use are one of the primary reasons for
hospitalization. When stopping the substance, patients with an alcohol use disorder can
suffer from a potentially fatal alcohol withdrawal syndrome. To mitigate these risks, a
withdrawal under medical supervision is possible, either in an outpatient setting or in
hospital, where the detoxification can be programmed or imposed. In the course of an alcohol
dependent patient's life, re-drinking is not exceptional and the patient may undergo several
withdrawals during his or her life.
Psychiatric pathologies, especially anxiety and depression, are more frequent in these
patients than in the rest of the population, just as can be somatic pathologies.e. Withdrawal
accidents, represented by comital seizures and delirium tremens, can be critical.
In hospital detoxifications, studies do not show any benefit in continuing the stay beyond 10
days, except in the case of somatic or psychiatric complication. However, little information
is available on the average length of stay for hospital alcohol detoxification.
Although alcohol dependence issues are very frequent and the resulting withdrawals are
relatively common and associated with numerous comorbidities, little data exists at a
national level in France.
The aim of this study is to describe these hospital detoxifications: course, duration,
frequency and clinical and paraclinical characteristics of the patients. We also wish to
analyze which characteristics are associated with longer stays or re-hospitalization and to
compare the care according to the facility type.
Objectives:
Main:
- To describe the clinical, paraclinical, and stay characteristics of hospital alcohol
detoxification in France
Secondary:
- To describe the regional distribution of hospital alcohol detoxification
- To evaluate whether certain clinical characteristics are associated with a longer
hospital stays
- To evaluate whether certain clinical characteristics are associated with subsequent
re-hospitalization for the same reason
- To compare the characteristics of patient stays by type of facility
Methods:
In this descriptive observational study using pre-existing data accessed via the PMSI
(Programme de Médicalisation des Systèmes d'Information), we will use all hospital stays from
2011 to 2020 for alcohol detoxification in France, both in public and private settings.
For each hospital stay will be collected the length, the antecedents of hospital alcohol
detoxification, clinical and psychiatric comorbidities, withdrawals complication, alcohol use
complication, further examinations.
We will describe the stays using median and quartiles for continuous variables and number and
percentage for dichotomous variables. For secondary objectives, we will use a multivariate
linear regression model if the length of stay is normal, an ordinal regression model
otherwise. The characteristics of the stays will be compared regarding the type of facility
using univariate comparative tests: Chi² or Fisher for dichotomous variables and Student or
Mann-Whitney for continuous variables.