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

Loss of Residual Renal Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01977716
• Other study ID #: R-2013-785-069
• Status: Not yet recruiting
• Phase: N/A
• First received: October 31, 2013
• Last updated: November 21, 2013
• Start date: December 2013
• Est. completion date: January 2016

Study information

• Verified date: October 2013
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: Ramon Paniagua, MD, PhD
• Phone: +52-55-56276900
• Email: jrpaniaguas[@]gmail.com
• Is FDA regulated: No
• Health authority: Mexico: Coordinación de Investigación en Salud
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Loss of Residual Renal Function
• Peritonitis
• Technique Failure in Peritoneal Dialysis

Locations

Country	Name	City	State
Mexico	Unidad de Investigación Médica en Enfermedades Nefrológicas, Instituto Mexicano del Seguro Social	Mexico City	DF

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Death		25 months	Yes
Primary	Loss of residual renal function		25 months	Yes
Primary	Technique (peritoneal dialysis) failure	Shift to hemodialysis	25 months	Yes