NCT01701687

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 3, 2015

Status Verified

July 1, 2015

Enrollment Period

2.8 years

First QC Date

October 3, 2012

Last Update Submit

July 31, 2015

Conditions

Alcoholic Liver DiseasesDecompensated Cirrhosis

Keywords

CirrhosisAlcoholic liver diseaseDecompensated liver cirrhosisHazardous alcohol

Outcome Measures

Primary Outcomes (1)

  • Liver Related Death

    The proportion of deaths up to 6 months from the baseline visit directly attributable to consequences of cirrhosis

    6 months

Secondary Outcomes (3)

  • Non-Liver related death

    6 months

  • Hospital Readmission

    6 months

  • Alcohol abstinence

    6 months

Study Arms (1)

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, Notts, NG7 2UH, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma and urine stored at -80 degrees centigrade under written patient consent

MeSH Terms

Conditions

Liver Diseases, AlcoholicFibrosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Neil Guha, MRCP, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2012

First Posted

October 5, 2012

Study Start

September 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 3, 2015

Record last verified: 2015-07

Locations

GB(1)