Status:
COMPLETED
Study of Exploratory Plasmatic Markers of Alcohol Withdrawal
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Alcohol Withdrawal
Eligibility:
All Genders
18-65 years
Brief Summary
This research focuses on alcohol withdrawal in hospitals and its potential neurological consequences. Alcohol withdrawal is an event that induces physical symptoms, such as tremors, sweating, anxiety...
Eligibility Criteria
Inclusion
- Admission for inpatient alcohol withdrawal (planned or unplanned)
- Last alcohol consumption less than 24 hours before admission to hospital
- Active alcohol use disorder (DSM 5 criteria)
- Age 18 to 65 years
- Affiliation to a social welfare system or beneficiary of such a system.
Exclusion
- Active use disorder of benzodiazepines, delta-9-tetrahydrocannabinol (THC), opioids, cocaine, amphetamines, new synthetic drug, gamma-hydroxybutyrate/gamma-butyrolactone, hallucinogens, assessed by interview
- Use in the previous 30 days of THC, opioids, cocaine, amphetamines, a new synthetic product, gamma-hydroxybutyrate/gamma-butyrolactone, hallucinogenic substances, assessed by questioning or positive by urine test,
- Patient on opioid maintenance therapy (methadone or buprenorphine)
- Presence of decompensated cirrhosis (Child Pugh score B or C) on admission or liver insufficiency with a TP \< 70%,
- Presence of severe acute alcoholic hepatitis (Maddrey score ≥32) on admission,
- Presence of chronic renal failure with a glomerular filtration rate of less than 60mL/minute/1.73m2 estimated by the Cockroft formula,
- Presence of acute renal failure,
- Presence of another condition that may cause brain damage :
- epileptic seizure, stroke, head trauma within the last three months,
- previously diagnosed severe cognitive impairment
- history or active infection with HIV, hepatitis C virus (HCV) or syphilis, known and noted in the medical record, collected in the history or noted in the systematic screening for sexually transmitted infections carried out for care,
- Patient with a language barrier (unable to follow the protocol or respond to clinical assessments),
- Hospitalization expected to be less than 15 days and not able to perform the protocol assay at D14,
- Pregnant, parturient or breastfeeding women,
- Person deprived of liberty by judicial or administrative decision,
- Person hospitalised without consent and not subject to a legal protection measure,
- Person subject to an exclusion period for other research,
- Adult person subject to a legal protection measure, adult person unable to express his or her consent and not subject to a protection measure.
Key Trial Info
Start Date :
April 19 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 17 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05216705
Start Date
April 19 2023
End Date
April 17 2024
Last Update
May 31 2024
Active Locations (1)
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1
GHU APHP Nord - Université de Paris, Site Lariboisière Fernand-Widal
Paris, France, F-75010