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

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: Recruiting
• Conditions: Hepatorenal Syndrome

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 (Estimated): 100

Contacts and Locations

• Study Contact: Name: Desmond Yap, MD; Phone Number: 85222553879; Email: desmondy@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital, Hong Kong
    • Contact: Desmond Yap, MD; Phone Number: 85222553879; Email: desmondy@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

How is the study designed?

Number of groups / cohorts

2

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	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Actual): June 1, 2012
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: April 30, 2015
• First Posted (Estimated): May 5, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease; Digestive System Diseases; Liver Diseases; Syndrome; Hepatorenal Syndrome
• Other Study ID Numbers: UW12342