Use of Novel Plasma and Urinary Biomarkers to Predict the Development of Hepatorenal Syndrome in Cirrhotic Patients

June 21, 2017 updated by: Dr. Desmond Yat-Hin Yap, The University of Hong Kong
This study investigated the use of novel plasma and urinary biomarkers to predicte the development of hepatorenal syndrome in patients with advanced cirrhosis. The biomarkers investigated include plasma cystatin C, plasma NGAL, plasma NAG, plasma IL-18, plasma ADMA, plasma BTP, urinary KIM-1 and urinary LFABP. These biomarkers will be checked in advanced cirrhotic patients who have or have not developed hepatorenal syndrome and compared between the two groups. These biomarkers will also be correlated with the occurence of hepatorenal syndrome.

Study Overview

Status

Unknown

Conditions

Detailed Description

This study investigated the use of novel plasma and urinary biomarkers to predicte the development of hepatorenal syndrome in patients with advanced cirrhosis. The biomarkers tested include plasma cystatin C, plasma NGAL, plasma NAG, plasma IL-18, plasma ADMA, plasma BTP, urinary KIM-1 and urinary LFABP. These biomarkers will be checked in advanced cirrhotic patients who have or have not developed hepatorenal syndrome and compared between the two groups. These biomarkers will also be correlated with the occurence of hepatorenal syndrome.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital, Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with advanced cirrhosis (Child's B or C) referred for liver transplantation

Description

Inclusion Criteria:

  • Patients with advanced cirrhosis (Child's B or C) referred for liver transplantation
  • Willing to give informed consent

Exclusion Criteria:

  • Patients with co-existing renal diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Hepatorenal syndrome group
Patients with advanced cirrhosis who develope hepatorenal syndrome
Non-hepatorenal syndrome group
Patients with advanced cirrhosis who do not hepatorenal syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hepatorenal syndrome
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 6 months
6 months
Chronic renal impairment
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

The Hong Kong Society of Nephrology

Investigators

  • Principal Investigator: Desmond Yap, MD, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

April 30, 2015

First Submitted That Met QC Criteria

April 30, 2015

First Posted (Estimate)

May 5, 2015

Study Record Updates

Last Update Posted (Actual)

June 22, 2017

Last Update Submitted That Met QC Criteria

June 21, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW12342

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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