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

• Conditions: Loss of Residual Renal Function; Technique Failure in Peritoneal Dialysis

• Registration Number: NCT01977716
• Lead Sponsor: Coordinación de Investigación en Salud, Mexico

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-10
• Study First Submitted: 2013-10-31
• Study First Submitted QC: 2013-10-31
• Study First Posted: 2013-11-07
• Last Update Submitted: 2013-11-21
• Last Update Posted: 2013-11-25
• Study Start: 2013-12
• Primary Completion: 2016-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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.

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Loss of residual renal function	25 months
Technique (peritoneal dialysis) failure	25 months	Shift to hemodialysis

Trial Locations

Locations (1)

Unidad de Investigación Médica en Enfermedades Nefrológicas, Instituto Mexicano del Seguro Social; 🇲🇽 Mexico City, DF, Mexico