Renal Function Determination in Patients With Liver Cirrhosis

June 7, 2016 updated by: ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

92

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

  • Mexico
    • DF
      • Mexico City, DF, Mexico, 14000
        • Instituto Nacional de Ciencias Médicas y Nutricion "Salvador Zubiran"

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients will be selected from the Liver Clinic from the Gastroenterology Department at a tertiary care center in Mexico

Description

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 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
Measure Description
Time Frame
Levels of glomerular filtration through several formulas in cirrhotic patients
Time Frame: Baseline
Determination of glomerular filtration through several formulas dependent of creatinine and cystatin C and the gold standard
Baseline

Collaborators and Investigators

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

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

  • Study Director: Aldo Torre, MD MSci, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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

April 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

January 23, 2014

First Submitted That Met QC Criteria

January 24, 2014

First Posted (Estimate)

January 28, 2014

Study Record Updates

Last Update Posted (Estimate)

June 8, 2016

Last Update Submitted That Met QC Criteria

June 7, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FILT01

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.

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