Peritonitis and Loss of Residual Renal Function, Technique Failure and Mortality in Peritoneal Dialysis Patients

The Role of Peritonitis in the Loss of Residual Renal Function, Technique Failure and Mortality in Peritoneal Dialysis Patients

The primary objective is to analyze peritonitis rate and peritonitis bacteriology as risk factors for loss of residual renal function, technique failure and mortality in chronic kidney disease patients.

Secondary objectives are: To know the current rate of peritonitis in peritoneal dialysis population and to understand the bacteriological profile of peritonitis.

To know the rate and risk factors other than peritonitis involved in the loss of residual renal function.

To analyze the utility of alternative diagnostic tests, such as reagent strips, for early detection of peritonitis when traditional tests are not available.

To analyze the simultaneous measurement of serum creatinine and cystatin-C as alternative measurements of peritoneal clearance and residual renal function.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • DF
      • Mexico City, DF, Mexico, 06722
        • Unidad de Investigación Médica en Enfermedades Nefrológicas, Instituto Mexicano del Seguro Social
        • Principal Investigator:
          • Ramon Paniagua, MD, PhD
        • Sub-Investigator:
          • Catarina Munguia-Miranda, MD
        • Sub-Investigator:
          • Maria de Jesus Ventura-Garcia, MSc

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients starting PD as the first dialysis treatment will be considered. Recruitment will take place over a six-months period in hospitals belonging to the Instituto Mexicano de Seguro Social. Inclusion criteria include: adult patients with signed informed consent given; there should not be selection for age, gender, primary cause of renal disease. Patients will not be included if they were previously in hemodialysis or received renal transplant. Patients will also be excluded if they are on immunosuppressive therapy, have diagnosis of cancer, or are seropositive for HIV or hepatitis.

Description

Inclusion Criteria:Inclusion criteria include: adult patients with signed informed consent given; there should not be selection for age, gender, primary cause of renal disease.

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Exclusion Criteria:Patients will not be included if they were previously in hemodialysis or received renal transplant. Patients will also be excluded if they are on immunosuppressive therapy, have diagnosis of cancer, or are seropositive for HIV or hepatitis.

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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

Cohorts and Interventions

Group / Cohort
Incident peritoneal dialysis patients
Patients with chronic kidney disease incident to peritoneal dialysis treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loss of residual renal function
Time Frame: 25 months
25 months
Technique (peritoneal dialysis) failure
Time Frame: 25 months
Shift to hemodialysis
25 months

Other Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: 25 months
25 months

Collaborators and Investigators

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

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, 2013

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

October 31, 2013

First Submitted That Met QC Criteria

October 31, 2013

First Posted (Estimate)

November 7, 2013

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 21, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

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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