NCT01701687|Completed
Biomarkers for the Prognosis of Decompensated Alcoholic Liver Disease
BANDED
The Feasibility of Liver Biomarkers as Prognostic Markers in Decompensated Alcoholic Liver Disease
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BANDED
The Feasibility of Liver Biomarkers as Prognostic Markers in Decompensated Alcoholic Liver Disease
Sponsor study identifier
observational
36
1 country
1
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2015
Actual (reported)Study Completion
July 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
October 3, 2012
Actual (reported)October 5, 2012
Actual (reported)July 2015
Actual (reported)July 2015
Actual (reported)Liver Related Death
The proportion of deaths up to 6 months from the baseline visit directly attributable to consequences of cirrhosis
6 months
Non-Liver related death
6 months
Hospital Readmission
6 months
Alcohol abstinence
6 months
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
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.
Nottingham University Hospitals NHS Trust
Nottingham, Notts, NG7 2UH, United Kingdom
Serum, plasma and urine stored at -80 degrees centigrade under written patient consent
Neil Guha, MRCP, PhD
University of Nottingham
36 participants (actual enrollment reported by the registry).
First Submitted
October 3, 2012
First Posted
October 5, 2012
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis
Contact the study team to confirm eligibility.
Primary Completion
July 2015
Actual (reported)Study Completion
July 2015
Actual (reported)Last Updated
August 3, 2015
Record last verified: 2015-07
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Source: ClinicalTrials.gov.
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