Biomarkers for the Prognosis of Decompensated Alcoholic Liver Disease (BANDED)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Nottingham
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01701687
First received: October 3, 2012
Last updated: January 16, 2014
Last verified: January 2014
  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

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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: 100
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (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

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  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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. 100 patients will be recruited for baseline visit over an 30 month study enrolment period, with a 6 month follow up period for all patients.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701687

Contacts
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

Locations
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   
Sponsors and Collaborators
University of Nottingham
National Institute for Health Research, United Kingdom
Investigators
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: January 16, 2014
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
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on September 18, 2014