Reduction of Exit Site Infection in Peritoneal Dialysis Patients

• Conditions: Peritoneal Dialysis Catheter Infection

• Registration Number: NCT03798171
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

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 Timeline

• Study Start: 2018-05-15
• Status Verified: 2019-01
• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-07
• Last Update Submitted: 2019-01-07
• Study First Posted: 2019-01-09
• Last Update Posted: 2019-01-09
• Primary Completion: 2021-05-15
• Study Completion: 2021-05-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

• patient's refusal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
exit-site infection rate	36 months	number of exit-site infection during 3 years of follow up, compared to historical data

Secondary Outcome Measures

Name	Time	Method
peritonitis rate	36 months	number of peritonitis episodes during 3 years of follow up, compared to historical data

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Canter; 🇮🇱 Tel Aviv, Israel