Biomarkers for the Prognosis of Decompensated Alcoholic Liver Disease (BANDED)
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Purpose
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.
| Condition |
|---|
|
Alcoholic Liver Diseases Decompensated Liver Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Feasibility of Liver Biomarkers as Prognostic Markers in Decompensated Alcoholic Liver Disease |
- Liver Related Death [ Time Frame: 6 months ] [ Designated as safety issue: No ]The proportion of deaths up to 6 months from the baseline visit directly attributable to consequences of cirrhosis
- Non-Liver related death [ Time Frame: 6 months ] [ Designated as safety issue: No ]Mortality unrelated to liver disease up to 6 months from baseline study visit
- Hospital Readmission [ Time Frame: 6 months ] [ Designated as safety issue: No ]Hospital readmission secondary to complications of cirrhosis
- Alcohol abstinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]Proportion of patients abstinent from alcohol at the 6 month timepoint
Biospecimen Retention: Samples Without DNA
Serum, plasma and urine stored frozen under written patient consent
| Estimated Enrollment: | 125 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Decompensated Alcoholic Cirrhosis
Recruited patients will have diagnosed liver cirrhosis (histological, radiological or accepted clinical parameters)admitted with an episode of decompensation. Patients must still be drinking hazardous alcohol quantities (>14 units for women, >21 units for men) at study enrollment
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Potentially eligible patients are adult patients with decompensated liver disease with alcohol as a major co-factor, and acutely admitted secondary to sequelae of hepatic decompensation. 125 patients will be recruited for baseline visit over an 18 month study enrolment period, with a 6 month follow up period for all patients.
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)
Contacts and Locations| Contact: Neil Guha, MRCP, PhD | 01159249924 ext 64415 | neil.guha@nottingham.ac.uk |
| Contact: David J Harman, MRCP | 01159249924 ext 70610 | david.harman@nottingham.ac.ukj |
| United Kingdom | |
| Nottingham University Hospitals NHS Trust | Recruiting |
| Nottingham, Notts, United Kingdom, NG7 2UH | |
| Contact: Neil Guha, MRCP, PhD 01159249924 ext 64415 neil.guha@nottingham.ac.uk | |
| Contact: David J Harman, MRCP 01159249924 ext 70610 david.harman@nottingham.ac.uk | |
| Principal Investigator: | Neil Guha, MRCP, PhD | University of Nottingham |
More Information
No publications provided
| Responsible Party: | University of Nottingham |
| ClinicalTrials.gov Identifier: | NCT01701687 History of Changes |
| Other Study ID Numbers: | 12050 |
| Study First Received: | October 3, 2012 |
| Last Updated: | October 3, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by University of Nottingham:
|
Cirrhosis Alcoholic liver disease Decompensated liver cirrhosis Hazardous alcohol |
Additional relevant MeSH terms:
|
Liver Diseases Liver Diseases, Alcoholic Digestive System Diseases |
Alcohol-Induced Disorders Alcohol-Related Disorders Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 16, 2013