Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-01-29 @ 1:43 AM
Study NCT ID:
NCT06838468
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-20
First Post:
2025-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
cACLD in Patients With Alcohol Use Disorder in the Hospital Detoxification Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2025-01-13', 'studyFirstSubmitQcDate': '2025-02-17', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of advanced chronic liver disease in patients who are electively admitted to the hospital alcohol detoxification unit', 'timeFrame': '5 days', 'description': 'Prevalence of pathological findings in the fibroscan that suggest compensated chronic liver disease'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic advance liver disease', 'detoxification unit', 'elastography', 'liver risk score'], 'conditions': ['Liver Disease Chronic', 'Cirrhosis', 'Detoxification', 'Alcohol Abuse/Dependence']}, 'referencesModule': {'references': [{'pmid': '37572680', 'type': 'RESULT', 'citation': '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': '26921783', 'type': 'RESULT', 'citation': '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': '29628280', 'type': 'RESULT', 'citation': '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': '23578009', 'type': 'RESULT', 'citation': "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': '27862159', 'type': 'RESULT', 'citation': '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': '20636661', 'type': 'RESULT', 'citation': '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': '34543610', 'type': 'RESULT', 'citation': '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': '7026710', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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", 'detailedDescription': "There is very little recent data on the prevalence of advance chronic liver disease in high-risk patients, particularly in our region, making studies evaluating this necessary.\n\nIn the European clinical practice guidelines (EASL Clinical Practice Guidelines: Management of Alcohol-Related Liver Disease), it is recommended to screen for advance chronic liver disease in high-risk populations such as patients in rehabilitation and detox clinics and heavy drinkers. advance chronic liver disease should be considered in patients presenting with extrahepatic manifestations of alcohol use disorder, such as peripheral symmetric neuropathy, pancreatitis, and cardiomyopathy, among others.\n\nScreening for liver disease in high-risk groups should not only include liver function tests (e.g., gamma-glutamyl transferase \\[GGT\\], alanine aminotransferase \\[ALT\\], or aspartate aminotransferase \\[AST\\]) but also include testing for liver fibrosis (e.g., transient elastography such as FibroScan®), given that advanced liver disease may occur in patients with normal liver profiles.\n\nIf any abnormalities are detected in liver profiles or elastography, an abdominal ultrasound should be performed to rule out hepatocellular carcinoma and a complete liver disease study should be carried out to exclude alternative or additional causes of liver damage. Current clinical guidelines (Spanish, European, and American) do not specify which tools to use in each risk subgroup.\n\nThe primary objective is to assess the prevalence of advance chronic liver disease measured by transient elastography in patients admitted to the Hospital Detoxification Unit and the acute psychiatric unit with dual pathology and harmful alcohol consumption.\n\nThis is a prospective, descriptive, single-center study conducted at Hospital Parc Taulí in Sabadell on patients admitted to the Hospital Detoxification Unit and the psychiatric unit with a diagnosis of dual pathology and harmful alcohol consumption. The study duration will be one year (from June 2024 to June 2025).\n\nWe will obtein clinical Variables like date of birth, sex, ethnicity, height, height, medical history (e.g., diagnosis of diabetes, dyslipidemia, hypertension, or underlying psychiatric disorder); Laboratory Variables: ALT, AST, alkaline phosphatase (ALP), GGT, total bilirubin, INR, platelets, glucose, HbA1c, total cholesterol, HDL, LDL, TSH, ferritin, and transferrin saturation. For patients with abnormal liver profiles, a second etiological study will be performed, including ceruloplasmin, copper, alpha-1 antitrypsin, ANA and SLA autoantibodies, immunoglobulins (IgA, IgG, IgM), and protein electrophoresis.\n\nElastography Variables: FibroScan® values and CAP (Control Attenuation Parameter) to estimate liver stiffness and quantify hepatic fat, respectively.\n\nRadiological Variables: Abdominal ultrasound findings (e.g., homogeneous or heterogeneous liver, presence of steatosis, nodular liver borders, splenomegaly, recanalization of the paraumbilical vein, collateral circulation, portal velocity, hepatic nodules). Endoscopic Variables: For patients diagnosed with advance chronic liver disease, esophagogastroduodenoscopy will be performed to rule out esophageal varices if criteria are met. Serological Variables for Fibrosis Estimation: LiverRisk score, APRI, FIB-4, Forns index, AAR (AST to ALT ratio).\n\nRegardless of liver profile abnormalities, an abdominal ultrasound will be requested to evaluate parenchymal changes and other indirect signs of liver disease and/or portal hypertension. Additional data collected by psychiatry will include the patient's date of birth, years of alcohol consumption, grams of alcohol/day measured in Standard Drink Units (SDUs), weight, height, relevant cardiovascular diseases (hypertension, diabetes, dyslipidemia), and underlying psychiatric disorders.\n\nA hepatology consultation will be requested, and FibroScan® will be performed during hospitalization. All fibrosis scores (LiverRisk score, APRI, FIB-4, Forns, and AAR) will be calculated using demographic and laboratory data.\n\nIf liver profile abnormalities are detected upon admission, a complete second etiological study will be requested.\n\nAll patients, regardless of whether they have advanced chronic liver disease or not, will be evaluated by a hepatologist who will provide information about the results of the diagnostic tests performed and the potential harmful effects of alcohol on the liver and overall health. This will reinforce the information provided by the psychiatrist in an effort to encourage the patient to cease alcohol consumption.\n\nIf the patient presents advance chronic liver disease (FibroScan® \\>8 KPa) or analytical, elastographic, or radiological evidence suggestive of cirrhosis will be referred to hepatology outpatient clinics for further evaluation and follow-up. Patients without advance chronic liver disease findings will be referred to primary care by their attending psychiatrist for follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the detoxification unit for alcohol use disorder or de psychiatry unit for dual pathology with harmful alcohol consumption', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to the detoxification unit for alcohol use disorder\n* 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))\n\nExclusion Criteria:\n\n* Refusal to undergo additional tests (blood analysis, ultrasound, and FibroScan)'}, 'identificationModule': {'nctId': 'NCT06838468', 'acronym': 'HEP-UHD', 'briefTitle': 'cACLD in Patients With Alcohol Use Disorder in the Hospital Detoxification Unit', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Detection of Advanced Chronic Liver Disease in Patients With Alcohol Use Disorder in the Hospital Detoxification Unit', 'orgStudyIdInfo': {'id': '2024/5057'}, 'secondaryIdInfos': [{'id': '2024/5057', 'type': 'OTHER', 'domain': 'CEIM Parc Tauli'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with excessive alcohol consumption admitted to the hospital detoxification unit', 'description': '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.', 'interventionNames': ['Diagnostic Test: Screening of compensated advance chronic liver disease']}], 'interventions': [{'name': 'Screening of compensated advance chronic liver disease', 'type': 'DIAGNOSTIC_TEST', 'description': '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.\n\nAnother 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.', 'armGroupLabels': ['Patients with excessive alcohol consumption admitted to the hospital detoxification unit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Consorci Corporació Sanitària Parc Taulí', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'overallOfficials': [{'name': 'Jordi Sánchez Delgado, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consorci Corporació Sanitària Parc Taulí'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'timeFrame': 'The information will be available at the end of the study in January 2026', 'ipdSharing': 'YES', 'description': 'Information about the project will be shared if another center is interested in participating and conducting a multicenter study', 'accessCriteria': 'Other researchers will have the opportunity to contact the principal investigator of the study and discuss any rellevant study information'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the hepatology hospitalization unit', 'investigatorFullName': 'Jordi Sanchez-Delgado', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}