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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Coordinación de Investigación en Salud, Mexico.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01977716
First Posted: November 7, 2013
Last Update Posted: November 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Coordinación de Investigación en Salud, Mexico
  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 ]
  • Technique (peritoneal dialysis) failure [ Time Frame: 25 months ]
    Shift to hemodialysis


Other Outcome Measures:
  • Death [ Time Frame: 25 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT01977716     History of Changes
Other Study ID Numbers: R-2013-785-069
First Submitted: October 31, 2013
First Posted: November 7, 2013
Last Update Posted: November 25, 2013
Last Verified: October 2013

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