- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04973202
Portrayal of Hospital Alcohol Detoxification in France (Alcostop)
Portrayal of Hospital Alcohol Detoxifications and Factors Associated With Longer or Ulterior Hospitalizations in France From 2011 to 2020
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
Montpellier, Francia, 34295
- Uhmontpellier
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Inpatients for alcohol detoxifications
French patients who were hospitalized for alcohol detoxification from 2011 to 2020
|
Stay for alcohol detoxification : routine care.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
description of age
Lasso di tempo: day 1 (At hospital inclusion)
|
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)
|
|
description of sex
Lasso di tempo: day 1 (At hospital inclusion)
|
Sex collected through the PMSI.
|
day 1 (At hospital inclusion)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
description of geographic code
Lasso di tempo: day 1 (At hospital inclusion)
|
Sex collected through the PMSI.
|
day 1 (At hospital inclusion)
|
|
description of CMU-C
Lasso di tempo: day 1 (At hospital inclusion)
|
CMU-C (universal complementary health insurance, collected through the PMSI.
|
day 1 (At hospital inclusion)
|
|
Length of stay
Lasso di tempo: During the stay (day 1 - day 15)
|
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)
|
|
Care establishment
Lasso di tempo: During the stay (day 1 - day 15)
|
Name and type of the care establishment, collected through the PMSI.
|
During the stay (day 1 - day 15)
|
|
Number of previous hospital detoxification stays in the studied period
Lasso di tempo: During the stay (day 1 - day 15)
|
Number of previous hospital detoxification stays in the studied period, collected through the PMSI.
|
During the stay (day 1 - day 15)
|
|
Psychiatric comorbidities
Lasso di tempo: During the stay (day 1 - day 15)
|
Psychiatric comorbidities (Major depression episode, anxiety, psychotic trouble, personality diseases), collected through the PMSI.
|
During the stay (day 1 - day 15)
|
|
Withdrawal complication
Lasso di tempo: During the stay (day 1 - day 15)
|
Withdrawal complications (delirium tremens, comitial seizures), collected through the PMSI.
|
During the stay (day 1 - day 15)
|
|
Further examination
Lasso di tempo: During the stay (day 1 - day 15)
|
Further examination (biology, imagery, etc…), collected through the PMSI.
|
During the stay (day 1 - day 15)
|
|
Re-hospitalization for same reason
Lasso di tempo: day 1
|
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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Lionel MOULIS, University Hospital, Montpellier
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RECHMPL21_0456
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Stay for alcohol detoxification
-
906 CMVI HoldingsCitruslabsAttivo, non reclutanteLibido | Problemi gastrointestinali | IntimitàStati Uniti