Assessment of Renal Function in Cirrhotic Patients

October 1, 2025 updated by: Baylor Research Institute

Assessment of Renal Function in Cirrhotic Patients -A Comparison of Cystatin C and Creatinine Based Calculations to 125I-iothalamate

The purpose of this study is to help determine whether cystatin C is a more sensitive laboratory measurement for renal function in cirrhotic patients.

Study Overview

Status

Completed

Detailed Description

Serum cystatin C, creatinine clearance based calculations, and 125I-Iothalamate clearance (Glofil) will be obtained in 220 patients with cirrhosis. Utilizing this information, the correlation between cystatin C and 125I-Iothalamate clearance will be obtained. In addition, the current serum creatinine based calculations and true creatinine clearance will also be correlated with 125I-Iothalamate clearance. The results of this study should help to determine whether serum cystatin C is a more sensitive laboratory measurement of renal function in patients with cirrhosis.

Study Type

Observational

Enrollment (Actual)

213

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

    • Texas
      • Fort Worth, Texas, United States, 76104
        • Baylor All Saint's Medical Center in Fort Worth

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients from Baylor All Saints Medical Center and Baylor University Medical Center who have cirrhosis and a stable urine creatinine

Description

Inclusion Criteria:

  • over 18 undergoing evaluation for a liver transplant

Exclusion Criteria:

  • known allergy or sensitivity to 125I-Iothalamate

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Creatinine based blood and urine laboratory tests as a measure of renal function in patients with chirrosis of the liver.
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Bernard Fischbach, MD, Baylor All Saints

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

December 1, 2010

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

January 13, 2025

Study Registration Dates

First Submitted

February 11, 2013

First Submitted That Met QC Criteria

July 5, 2013

First Posted (Estimated)

July 10, 2013

Study Record Updates

Last Update Posted (Estimated)

October 6, 2025

Last Update Submitted That Met QC Criteria

October 1, 2025

Last Verified

July 1, 2015

More Information

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.

Clinical Trials on Liver Failure

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