- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
-
Montpellier, Frankreich, 34295
- UHMontpellier
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
---|---|
Inpatients for alcohol detoxifications
French patients who were hospitalized for alcohol detoxification from 2011 to 2020
|
Stay for alcohol detoxification : routine care.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
description of age
Zeitfenster: 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
Zeitfenster: day 1 (At hospital inclusion)
|
Sex collected through the PMSI.
|
day 1 (At hospital inclusion)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
description of geographic code
Zeitfenster: day 1 (At hospital inclusion)
|
Sex collected through the PMSI.
|
day 1 (At hospital inclusion)
|
description of CMU-C
Zeitfenster: day 1 (At hospital inclusion)
|
CMU-C (universal complementary health insurance, collected through the PMSI.
|
day 1 (At hospital inclusion)
|
Length of stay
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Lionel MOULIS, University Hospital, Montpellier
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RECHMPL21_0456
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Stay for alcohol detoxification
-
906 CMVI HoldingsCitruslabsAktiv, nicht rekrutierendLibido | Magen-Darm-Probleme | IntimitätVereinigte Staaten