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Reduction of Exit Site Infection in Peritoneal Dialysis Patients

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.
 
ClinicalTrials.gov Identifier: NCT03798171
Recruitment Status : Unknown
Verified January 2019 by michal roll, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

Study Description
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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
Peritoneal Dialysis Catheter Infection

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
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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : May 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. exit-site infection rate [ Time Frame: 36 months ]
    number of exit-site infection during 3 years of follow up, compared to historical data


Secondary Outcome Measures :
  1. peritonitis rate [ Time Frame: 36 months ]
    number of peritonitis episodes during 3 years of follow up, compared to historical data


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
peritoneal dialysis patients in Tel Aviv Sourasky medical center
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patient's refusal
Contacts and Locations
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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): NCT03798171


Locations
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Israel
Tel Aviv Sourasky Medical Canter Recruiting
Tel Aviv, Israel
Contact: Orit Kliuk Ben Bassat, MD    97236973270    oritkl@tlvmc.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
More Information
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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: January 9, 2019    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by michal roll, Tel-Aviv Sourasky Medical Center:
peritoneal dialysis
exit site
infection
peritonitis
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Disease Attributes
Pathologic Processes