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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Coordinación de Investigación en Salud, Mexico
Sponsor:
Information provided by (Responsible Party):
Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier:
NCT01977716
First received: October 31, 2013
Last updated: November 21, 2013
Last verified: October 2013
  Purpose

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.


Condition
Loss of Residual Renal Function
Technique Failure in Peritoneal Dialysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Peritonitis in the Loss of Residual Renal Function, Technique Failure and Mortality in Peritoneal Dialysis Patients

Resource links provided by NLM:


Further study details as provided by Coordinación de Investigación en Salud, Mexico:

Primary Outcome Measures:
  • Loss of residual renal function [ Time Frame: 25 months ] [ Designated as safety issue: Yes ]
  • Technique (peritoneal dialysis) failure [ Time Frame: 25 months ] [ Designated as safety issue: Yes ]
    Shift to hemodialysis


Other Outcome Measures:
  • Death [ Time Frame: 25 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 350
Study Start Date: December 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Incident peritoneal dialysis patients
Patients with chronic kidney disease incident to peritoneal dialysis treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01977716

Contacts
Contact: Ramon Paniagua, MD, PhD +52-55-56276900 ext 21371 jrpaniaguas@gmail.com

Locations
Mexico
Unidad de Investigación Médica en Enfermedades Nefrológicas, Instituto Mexicano del Seguro Social Not yet recruiting
Mexico City, DF, Mexico, 06722
Principal Investigator: Ramon Paniagua, MD, PhD         
Sub-Investigator: Catarina Munguia-Miranda, MD         
Sub-Investigator: Maria de Jesus Ventura-Garcia, MSc         
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
  More Information

No publications provided

Responsible Party: Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT01977716     History of Changes
Other Study ID Numbers: R-2013-785-069
Study First Received: October 31, 2013
Last Updated: November 21, 2013
Health Authority: Mexico: Coordinación de Investigación en Salud

Keywords provided by Coordinación de Investigación en Salud, Mexico:
Peritonitis
loss of residual renal function
technique survival

Additional relevant MeSH terms:
Peritonitis
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 19, 2014