Decompensated Cirrhosis Clinical Trial
— BANDEDOfficial title:
The Feasibility of Liver Biomarkers as Prognostic Markers in Decompensated Alcoholic Liver Disease
Verified date | July 2015 |
Source | University of Nottingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Observational |
Fibroscan is a non invasive imaging investigation which measures liver stiffness, known to correlate well with liver scarring and cirrhosis on liver biopsy. Indocyanine green is an inert dye which is purely extracted from the blood by liver cells, and is hence an excellent marker of both liver cell function and overall liver blood flow. There is little data for either of these biomarkers regarding outcomes in alcoholic liver disease. We aim to establish the accuracy of these liver biomarkers in predicting important liver related outcomes (death, transplantation and hospital readmission with cirrhosis related consequences) in patients with severe (decompensated) alcoholic liver disease. Moreover, we will assess whether the serial measurement of biomarkers has any impact on alcohol abstinence, motivation or quality of life. Over an 18 month period, 125 consecutive hospital inpatients with decompensated alcoholic liver disease will undergo baseline biomarker measurement, routine blood and urine tests and qualitative questionnaires. These will be measured during their initial hospital admission (0 months) with subsequent repeat measurement during follow up visits at 1, 2, 4 and 6 months. Each study visit time will be in the region of 30-40 minutes to complete these investigations. The end of the study for individual patients will be patient death, liver transplantation or 6 month from study enrolment; whichever occurs first.
Status | Completed |
Enrollment | 36 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Male or female patients 18-75 years of age - Diagnosis of cirrhosis based upon: - a) Histological confirmation - b) Combination of clinical and radiological criteria - c) Validated non invasive biomarker - Alcohol as the primary aetiology for liver cirrhosis - Hospital admission related to decompensated liver disease (e.g. ascites, varices, sepsis, alcoholic hepatitis) - Active alcohol drinking prior to index hospital admission Exclusion Criteria: - Grade 3 or 4 hepatic encephalopathy - Hepatocellular carcinoma - Active non hepatic malignancy - Known complete portal vein thrombosis - Alcohol abstinence at time of index hospital admission - Pregnancy - Active cardiac devices (e.g. cardiac pacemaker, implantable cardioverter defibrillator) |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham | Notts |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham | National Institute for Health Research, United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Liver Related Death | The proportion of deaths up to 6 months from the baseline visit directly attributable to consequences of cirrhosis | 6 months | No |
Secondary | Non-Liver related death | Mortality unrelated to liver disease up to 6 months from baseline study visit | 6 months | No |
Secondary | Hospital Readmission | Hospital readmission secondary to complications of cirrhosis | 6 months | No |
Secondary | Alcohol abstinence | Proportion of patients abstinent from alcohol at the 6 month timepoint | 6 months | No |
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