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Reduction of Exit Site Infection in Peritoneal Dialysis Patients

Sponsor
Tel-Aviv Sourasky Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03798171
Collaborator
(none)
80
Enrollment
1
Location
36
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In peritoneal dialysis patients, the presence of the catheter presents a risk of infection - exit site infection, tunnel infection or peritonitis. In our dialysis unit, we noticed a rise in exit-site infection associated with organisms derived from contaminated water. Therefore we decided to change the exit-site care in our unit.

This is a prospective observational single center study, that compares exit-site infection rated in peritoneal dialysis patients before and after our policy change for exit-site care.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Peritoneal dialysis is a method for renal replacement therapy that uses the peritoneal membrane for exchange of fluids and dissolved substance . A catheter is surgically inserted with one end in the abdomen and the other protruding from the skin, in order to allow fluid exchange.

    The presence of the catheter presents a risk of infection - exit site infection, tunnel infection or peritonitis - a cause of morbidity and treatment failure.

    Infection prevention is based, among other measures, on aseptic handeling of catheter exit-site. In our dialysis unit, we noticed a rise in pseudomonas exit-site infection and other organisms associated with contaminated water. Therefore we decided to change the exit-site care in our unit. Similar to central catheters handeling, we decided to cover the catheter exit-site during water exposure, and to change the prophylactic exit-site antibiotic regimen.

    This is a prospective observational single center study. All peritoneal dialysis patients in our institue will be counseled about change in exit-site care. For prevention of water exposure the patients will use stoma bags around the catheter during showers. After the shower, the exit-site is cleaned with a chlorhexidine based solution, an antibiotic cream is applied (Mupirocin) and dressed with a clean gauze.

    The patients will be followed for 3 years for adverse events. The number of infectious episodes will be recorded and compared to historical data (January 2015-December 2017).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Reduction of Exit Site Infection in Peritoneal Dialysis Patients
    Actual Study Start Date :
    May 15, 2018
    Anticipated Primary Completion Date :
    May 15, 2021
    Anticipated Study Completion Date :
    May 15, 2021

    Outcome Measures

    Primary Outcome Measures

    1. exit-site infection rate [36 months]

      number of exit-site infection during 3 years of follow up, compared to historical data

    Secondary Outcome Measures

    1. peritonitis rate [36 months]

      number of peritonitis episodes during 3 years of follow up, compared to historical data

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • peritoneal dialysis patients capable to sign an informed consent or have an official guardian
    Exclusion Criteria:
    • patient's refusal

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tel Aviv Sourasky Medical Canter Tel Aviv Israel

    Sponsors and Collaborators

    • Tel-Aviv Sourasky Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    michal roll, Department of nephrology, Tel-Aviv Sourasky Medical Center
    ClinicalTrials.gov Identifier:
    NCT03798171
    Other Study ID Numbers:
    • 0077-18-TLV
    First Posted:
    Jan 9, 2019
    Last Update Posted:
    Jan 9, 2019
    Last Verified:
    Jan 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by michal roll, Department of nephrology, Tel-Aviv Sourasky Medical Center
    peritoneal dialysis
    exit site
    infection
    peritonitis
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases

    Study Results

    No Results Posted as of Jan 9, 2019