cACLD in Patients With Alcohol Use Disorder in the Hospital Detoxification Unit

NCT06838468 | Enrolling By Invitation DMC

• 1 other identifier: 2024/5057
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to conduct a quick assessment of potential liver damage caused by chronic alcohol consumption. Taking advantage of the patient's admission to a specialized detoxification unit, several tests will be performed to determine the extent of liver damage through blood tests, ultrasound, and FibroScan

Conditions

Liver Disease Chronic; Cirrhosis; Detoxification; Alcohol Abuse/Dependence

Keywords

chronic advance liver disease; detoxification unit; elastography; liver risk score

Outcome Measures

Primary Outcomes (1)

• Prevalence of advanced chronic liver disease in patients who are electively admitted to the hospital alcohol detoxification unit

  Prevalence of pathological findings in the fibroscan that suggest compensated chronic liver disease

  5 days

Study Arms (1)

Patients with excessive alcohol consumption admitted to the hospital detoxification unit

The intervention performed on patients who have been electively admitted to the hospital detoxification unit consists of diagnostic tests to assess potential liver damage secondary to alcohol consumption. These are usually young patients with very high alcohol intake who, under normal circumstances, would need to be evaluated on an outpatient basis. Since the potential prevalence of advanced liver disease is expected to be higher in this subgroup of patients, the hospital stay is utilized to carry out all these tests quickly. The tests performed will include a general blood analysis to evaluate liver and kidney function, an assessment of the prevalence of metabolic diseases such as obesity, hypertension, or diabetes, an abdominal ultrasound, and elastography to assess liver stiffness.

Diagnostic Test: Screening of compensated advance chronic liver disease

Interventions

Screening of compensated advance chronic liver disease DIAGNOSTIC_TEST

The tests performed will include a general blood analysis to evaluate liver and kidney function, an assessment of the prevalence of metabolic diseases such as obesity, hypertension, or diabetes, an abdominal ultrasound, and elastography to assess liver stiffness. Another intervention to be studied is whether the request for diagnostic tests to evaluate liver disease, as well as the visit of the hepatologist during hospitalization in the detoxification unit, influences subsequent alcohol abstinence. To this end, abstinence will be assessed six months after admission to the alcohol detoxification unit and compared with a retrospective cohort of patients admitted to the detoxification unit one year ago, in whom no liver disease evaluation was conducted neither information of potencial liver damage was offered by hepatologist and the intervention was carried out only by the psychiatrists responsible for the unit.

Patients with excessive alcohol consumption admitted to the hospital detoxification unit

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the detoxification unit for alcohol use disorder or de psychiatry unit for dual pathology with harmful alcohol consumption

You may qualify if:

• Patients admitted to the detoxification unit for alcohol use disorder
• Patients admitted to the psychiatry unit for dual pathology with harmful alcohol consumption (\> 30 g/day in men (3 standard drinks) and \> 20 g/day in women (2 standard drinks))

You may not qualify if:

• Refusal to undergo additional tests (blood analysis, ultrasound, and FibroScan)

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Consorci Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (8)

• Serra-Burriel M, Juanola A, Serra-Burriel F, Thiele M, Graupera I, Pose E, Pera G, Grgurevic I, Caballeria L, Piano S, van Kleef L, Reichert M, Roulot D, Pericas JM, Schattenberg JM, Tsochatztis EA, Guha IN, Garcia-Retortillo M, Hernandez R, Hoyo J, Fuentes M, Exposito C, Martinez A, Such P, Madir A, Detlefsen S, Tonon M, Martini A, Ma AT, Pich J, Bonfill E, Juan M, Soria A, Carol M, Gratacos-Gines J, Morillas RM, Toran P, Navarrete JM, Torrejon A, Fournier C, Llorca A, Arslanow A, de Koning HJ, Cucchietti F, Manns M, Newsome PN, Hernaez R, Allen A, Angeli P, de Knegt RJ, Karlsen TH, Galle P, Wong VW, Fabrellas N, Castera L, Krag A, Lammert F, Kamath PS, Gines P; LiverScreen Consortium Investigators. Development, validation, and prognostic evaluation of a risk score for long-term liver-related outcomes in the general population: a multicohort study. Lancet. 2023 Sep 16;402(10406):988-996. doi: 10.1016/S0140-6736(23)01174-1. Epub 2023 Aug 9.

  PMID: 37572680 RESULT

• Crabb DW, Bataller R, Chalasani NP, Kamath PS, Lucey M, Mathurin P, McClain C, McCullough A, Mitchell MC, Morgan TR, Nagy L, Radaeva S, Sanyal A, Shah V, Szabo G; NIAAA Alcoholic Hepatitis Consortia. Standard Definitions and Common Data Elements for Clinical Trials in Patients With Alcoholic Hepatitis: Recommendation From the NIAAA Alcoholic Hepatitis Consortia. Gastroenterology. 2016 Apr;150(4):785-90. doi: 10.1053/j.gastro.2016.02.042. Epub 2016 Feb 24. No abstract available.

  PMID: 26921783 RESULT

• European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of alcohol-related liver disease. J Hepatol. 2018 Jul;69(1):154-181. doi: 10.1016/j.jhep.2018.03.018. Epub 2018 Apr 5. No abstract available.

  PMID: 29628280 RESULT

• Addolorato G, Mirijello A, Leggio L, Ferrulli A, D'Angelo C, Vassallo G, Cossari A, Gasbarrini G, Landolfi R, Agnes S, Gasbarrini A; Gemelli OLT Group. Liver transplantation in alcoholic patients: impact of an alcohol addiction unit within a liver transplant center. Alcohol Clin Exp Res. 2013 Sep;37(9):1601-8. doi: 10.1111/acer.12117. Epub 2013 Apr 11.

  PMID: 23578009 RESULT

• Askgaard G, Leon DA, Kjaer MS, Deleuran T, Gerds TA, Tolstrup JS. Risk for alcoholic liver cirrhosis after an initial hospital contact with alcohol problems: A nationwide prospective cohort study. Hepatology. 2017 Mar;65(3):929-937. doi: 10.1002/hep.28943. Epub 2017 Jan 6.

  PMID: 27862159 RESULT

• Rehm J, Taylor B, Mohapatra S, Irving H, Baliunas D, Patra J, Roerecke M. Alcohol as a risk factor for liver cirrhosis: a systematic review and meta-analysis. Drug Alcohol Rev. 2010 Jul;29(4):437-45. doi: 10.1111/j.1465-3362.2009.00153.x.

  PMID: 20636661 RESULT

• Gines P, Krag A, Abraldes JG, Sola E, Fabrellas N, Kamath PS. Liver cirrhosis. Lancet. 2021 Oct 9;398(10308):1359-1376. doi: 10.1016/S0140-6736(21)01374-X. Epub 2021 Sep 17.

  PMID: 34543610 RESULT

• Passi S, Rothschild-Boros MC, Fasella P, Nazzaro-Porro M, Whitehouse D. An application of high performance liquid chromatography to analysis of lipids in archaeological samples. J Lipid Res. 1981 Jul;22(5):778-84.

  PMID: 7026710 RESULT

MeSH Terms

Conditions

Fibrosis; Alcoholism

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jordi Sánchez Delgado, MD. PhD

  Consorci Corporació Sanitària Parc Taulí

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the hepatology hospitalization unit

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: February 20, 2025
• Study Start: March 6, 2024
• Primary Completion: March 12, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: The information will be available at the end of the study in January 2026
• Access Criteria: Other researchers will have the opportunity to contact the principal investigator of the study and discuss any rellevant study information

Locations

ES (1)