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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.


Recruitment information / eligibility

Status Completed
Enrollment 50000
Est. completion date August 30, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: Inclusion criteria: - French patients of at least 18 years old - Inpatients of a public or private care facility for alcohol detoxification - From 01/01/2011 to 12/31/2020 - In a medical or psychiatric hospital Exclusion criteria: - age < 18 years

Study Design


Intervention

Other:
Stay for alcohol detoxification
Stay for alcohol detoxification : routine care.

Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary description of age Age at admission (in years), calculated by the difference of the year of admission and the year of birth through the PMSI. day 1 (At hospital inclusion)
Primary description of sex Sex collected through the PMSI. day 1 (At hospital inclusion)
Secondary description of geographic code Sex collected through the PMSI. day 1 (At hospital inclusion)
Secondary description of CMU-C CMU-C (universal complementary health insurance, collected through the PMSI. day 1 (At hospital inclusion)
Secondary Length of stay Length of stay (in days), calculated by the difference between the discharge date and the entry date, collected through the PMSI. During the stay (day 1 - day 15)
Secondary Care establishment Name and type of the care establishment, collected through the PMSI. During the stay (day 1 - day 15)
Secondary Number of previous hospital detoxification stays in the studied period Number of previous hospital detoxification stays in the studied period, collected through the PMSI. During the stay (day 1 - day 15)
Secondary Psychiatric comorbidities Psychiatric comorbidities (Major depression episode, anxiety, psychotic trouble, personality diseases), collected through the PMSI. During the stay (day 1 - day 15)
Secondary Withdrawal complication Withdrawal complications (delirium tremens, comitial seizures), collected through the PMSI. During the stay (day 1 - day 15)
Secondary Further examination Further examination (biology, imagery, etc…), collected through the PMSI. During the stay (day 1 - day 15)
Secondary Re-hospitalization for same reason For each patient, and each stay, we will evaluate if the patient had an ulterior re-hospitalization for alcohol withdrawal. Collected through the PMSI. day 1
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