NCT01071746

Brief Summary

Patients with acute on chronic liver failure have a risk of developing multiorgan failure and a high mortality. The current scoring systems defining the outcome of patients with acute decompensation of cirrhosis fail to identify patients that progress to Acute-on-chronic liver failure (ACLF). The aim of the study is to evaluate if one can identify these patients early on with the proposed biomarkers: dimethylarginines and ischemia modified albumin.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

February 19, 2010

Status Verified

April 1, 2008

Enrollment Period

2.2 years

First QC Date

February 18, 2010

Last Update Submit

February 18, 2010

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Progress to ACLF

    hours, days

Secondary Outcomes (1)

  • Prognosticate ACLF

    Days

Study Arms (1)

Acute decompensation of cirrhosis

acute decompensation of liver function occuring secondary to precipitating events such as sepsis, GI bleed.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Inpatients with acute clinical deterioration of cirrhosis.

You may qualify if:

  • All patients with an acute clinical decompensation of presumed cirrhosis (elevated bilirubin \>85 µmol/L, or/and increasing ascites or/and hepatic encephalopathy \< grade 2) related to a clear precipitating event (e.g. infection, bleeding, alcoholic hepatitis, exposure to hepatotoxin)

You may not qualify if:

  • Admission for reasons other than decompensation of cirrhosis (other co-morbid diseases, especially established cardiovascular or renal disease (U/S).
  • Malignancy (extra-hepatic or a hepatocellular carcinoma).
  • Patients who have undergone major surgery or have unsolved surgical problems.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London Hospital

London, WC1E 6HX, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

RNA

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rajeshwar P Mookerjee, BScMRCPPhD

    University College London Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajeshwar P Mookerjee, BScMRCPPhD

CONTACT

02076796516r.mookerjee@ucl.ac.uk

Naina Shah, MBBSMRCP

CONTACT

02076796516naina.shah@ucl.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 18, 2010

First Posted

February 19, 2010

Study Start

September 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

February 19, 2010

Record last verified: 2008-04

Locations

GB(1)