Reduction of Exit Site Infection in Peritoneal Dialysis Patients

January 7, 2019 updated by: michal roll, Tel-Aviv Sourasky Medical Center

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Recruiting
        • Tel Aviv Sourasky Medical canter
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

peritoneal dialysis patients in Tel Aviv Sourasky medical center

Description

Inclusion Criteria:

  • peritoneal dialysis patients capable to sign an informed consent or have an official guardian

Exclusion Criteria:

  • patient's refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
exit-site infection rate
Time Frame: 36 months
number of exit-site infection during 3 years of follow up, compared to historical data
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
peritonitis rate
Time Frame: 36 months
number of peritonitis episodes during 3 years of follow up, compared to historical data
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2018

Primary Completion (Anticipated)

May 15, 2021

Study Completion (Anticipated)

May 15, 2021

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

January 7, 2019

First Posted (Actual)

January 9, 2019

Study Record Updates

Last Update Posted (Actual)

January 9, 2019

Last Update Submitted That Met QC Criteria

January 7, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0077-18-TLV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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