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NCT02047240 Clinical Trial

Renal Function Determination in Patients With Liver Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:
Renal Function Determination With Creatinine and Cystatin C Dependent Formulas Compared to Gold Standard DTPA-TC-99 (Diethylene-triamine-pentaacetate- Technetium-99) in Mexican Cirrhotic Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02047240
Other study ID # FILT01
Secondary ID
Status Completed
Phase N/A
First received January 23, 2014
Last updated June 7, 2016
Start date April 2013
Est. completion date April 2016

Study information
Verified date June 2016
Source Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Contact n/a
Is FDA regulated No
Health authority Mexico: Secretaria de Salud
Study type Observational

Clinical Trial Summary

We have several ways to appropriately determine renal function in healthy patients and in several diseases, in cirrhotic population we dont have a precise tool that has sufficient precision that reflects glomerular function, although it has been reported that cystatin C, because of its nature could improve diagnostic accuracy to determinate the renal function in this population.

The investigators hypothesize that glomerular filtration obtained from cystatin-C-derived formulas are more accurate when compared to creatinine-derived formulas with DTPA-Tc99 (diethylene-triamine-pentaacetate- technetium-99) as gold standard.

Description:

The aim of the study is to determine if the formulas for glomerular filtration are close to the estimation of actual renal function in mexican cirrhotic patients of different etiologies.

Recruitment information / eligibility
Status Completed
Enrollment 92
Est. completion date April 2016
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Liver cirrhosis

- Stability in creatinine levels in the previous three months (variation <0.3 mg/dL)

- Signed informed consent

Exclusion Criteria:

- Pregnancy

- Hepatocellular carcinoma

- Cerebrovascular events

- Decompensated heart failure

- Drugs that modify serum creatinine levels

- Renal replacement therapy

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Mexico Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán" Mexico City DF

Sponsors (1)
Lead Sponsor Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Levels of glomerular filtration through several formulas in cirrhotic patients Determination of glomerular filtration through several formulas dependent of creatinine and cystatin C and the gold standard Baseline No
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