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NCT02434445 Clinical Trial

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

Hepatorenal Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02434445
Other study ID # UW12342
Secondary ID
Status Recruiting
Phase N/A
First received April 30, 2015
Last updated June 21, 2017
Start date July 2012
Est. completion date July 2018

Study information
Verified date June 2017
Source The University of Hong Kong
Contact Desmond Yap, MD
Phone 85222553879
Email desmondy@hku.hk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date July 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Hong Kong Queen Mary Hospital, Hong Kong Hong Kong

Sponsors (2)
Lead Sponsor Collaborator
The University of Hong Kong The Hong Kong Society of Nephrology

Country where clinical trial is conducted

Hong Kong, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hepatorenal syndrome 12 weeks
Secondary Mortality 6 months
Secondary Chronic renal impairment 6 months
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