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NCT01895114 Clinical Trial

Assessment of Renal Function in Cirrhotic Patients

Renal Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01895114
Other study ID # 010-263
Secondary ID
Status Recruiting
Phase N/A
First received February 11, 2013
Last updated July 27, 2015
Start date December 2010
Est. completion date December 2015

Study information
Verified date July 2015
Source Baylor Research Institute
Contact Erin Fassett, RN
Phone 817-922-7667
Email Erin.Fassett@baylorhealth.edu
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- over 18 undergoing evaluation for a liver transplant

Exclusion Criteria:

- known allergy or sensitivity to 125I-Iothalamate

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Baylor All Saint's Medical Center in Fort Worth Fort Worth Texas

Sponsors (1)
Lead Sponsor Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Creatinine based blood and urine laboratory tests as a measure of renal function in patients with chirrosis of the liver. 24 hours No
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