- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01977716
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
Status
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ramon Paniagua, MD, PhD
- Phone Number: 21371 +52-55-56276900
- Email: jrpaniaguas@gmail.com
Study Locations
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DF
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Mexico City, DF, Mexico, 06722
- Unidad de Investigación Médica en Enfermedades Nefrológicas, Instituto Mexicano del Seguro Social
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Principal Investigator:
- Ramon Paniagua, MD, PhD
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Sub-Investigator:
- Catarina Munguia-Miranda, MD
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Sub-Investigator:
- Maria de Jesus Ventura-Garcia, MSc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Incident peritoneal dialysis patients
Patients with chronic kidney disease incident to peritoneal dialysis treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Loss of residual renal function
Time Frame: 25 months
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25 months
|
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Technique (peritoneal dialysis) failure
Time Frame: 25 months
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Shift to hemodialysis
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25 months
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Death
Time Frame: 25 months
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25 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-2013-785-069
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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