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Occurrence of Emerging Infections After Placement of a Peritoneal Dialysis CatHeter (SINEPHILE)

Primary Purpose

End Stage Renal Disease on Dialysis, Peritoneal Dialysis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaire
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for End Stage Renal Disease on Dialysis focused on measuring Renal disease, Peritoneal dialysis, Emergence infections

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women aged 18 to 80 inclusive
  • Signature of informed consent
  • Affiliation to a French social security scheme
  • Patient with end stage renal disease starting renal replacement therapy by peritoneal dialysis in one of the participating centers

Exclusion Criteria:

  • Legal incapacity or limited legal capacity
  • Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator
  • Pregnant woman
  • Subject being in the period of exclusion from another study or provided for by the "national file of volunteers".
  • Patient without health insurance
  • Inability to understand the reasons for the study; psychiatric disorder judged by the investigator to be incompatible with inclusion in the study.

Sites / Locations

  • Service de néphrologie, CHU de BesançonRecruiting
  • Besancon University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Only experimental arm

Arm Description

Only experimental arm. Patients filling out questionnaires.

Outcomes

Primary Outcome Measures

Risk of infections on emergence site
The risk of infections on emergence site of placing a peritoneal dialysis catheter. The infection of the site of emergence is defined by the practitioner as a minimum according to the recommendations: "the presence of a purulent discharge, with or without erythema of the skin at the catheter-epidermal interface" and inducing treatment with an antibiotic .

Secondary Outcome Measures

Full Information

First Posted
January 26, 2021
Last Updated
August 1, 2022
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT04730830
Brief Title
Occurrence of Emerging Infections After Placement of a Peritoneal Dialysis CatHeter
Acronym
SINEPHILE
Official Title
Survenue Des Infections d'Emergence après la Pose d'un catHéter de Dialyse péritonéaLE
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Peritoneal dialysis, which appeared at the end of the 1970s, quickly proved its worth both in terms of its effectiveness and of its ease of compliance, which guarantees an improved quality of life. To date there are different modes of application of this technique: Continuous Ambulatory Peritoneal Dialysis, and Automated Peritoneal Dialysis. Whatever the technique used, the placement of a dressing covering the exit site of the catheter is necessary just after the placement of the PD catheter and this so that the site of emergence is kept dry until healing (in general 2 to 4 weeks). Once the emergence site has healed, the technique can be started. Discharge site infections are a major predisposing factor for the development of peritonitis. Numerous studies in different parts of the world have shown that the rates of PD-related infections have steadily declined over the past 10 to 20 years. Several recommendations for the prevention and treatment of emergence site infections have been published by the International Peritoneal Dialysis Society. Several studies nonetheless call into question the recommendations by showing that catheter infection is not linked to the number of risk factors present at the time of catheter insertion, nor to the prescription of antibiotic prophylaxis, nor to the the experience of the caregiver, the antiseptic used or the early dressing change. In addition, only antibiotic prophylaxis at catheter placement is strongly recommended. Regarding the other measures, their relevance is not always demonstrated and their application varies considerably from one center to another. In addition, many authors have sought to establish a definition of catheter infections in order to allow an optimal assessment of their frequency. However, these definitions are not universal and have certain limitations. The objective of this work is on the one hand to better characterize the incidence of infections at the site of emergence in peritoneal dialysis, and on the other hand, in the absence of a definition established according to the recommendations, to use the score de Schaeffer, is in particular the value of this score which would make it possible to define more precisely the presence of an infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease on Dialysis, Peritoneal Dialysis
Keywords
Renal disease, Peritoneal dialysis, Emergence infections

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Observational study with questionnaires
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Only experimental arm
Arm Type
Experimental
Arm Description
Only experimental arm. Patients filling out questionnaires.
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
Patients completing emergence assessment questionnaires at the time of the first dressing placement, as well as at the scheduled weekly placement. As part of a planned repair, the emergence will be assessed at most once a week, preferably at the beginning of the week by the patient. In any other case of dressing change, an emergence assessment will be requested.
Primary Outcome Measure Information:
Title
Risk of infections on emergence site
Description
The risk of infections on emergence site of placing a peritoneal dialysis catheter. The infection of the site of emergence is defined by the practitioner as a minimum according to the recommendations: "the presence of a purulent discharge, with or without erythema of the skin at the catheter-epidermal interface" and inducing treatment with an antibiotic .
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women aged 18 to 80 inclusive Signature of informed consent Affiliation to a French social security scheme Patient with end stage renal disease starting renal replacement therapy by peritoneal dialysis in one of the participating centers Exclusion Criteria: Legal incapacity or limited legal capacity Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator Pregnant woman Subject being in the period of exclusion from another study or provided for by the "national file of volunteers". Patient without health insurance Inability to understand the reasons for the study; psychiatric disorder judged by the investigator to be incompatible with inclusion in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie Gaiffe, PhD
Phone
+33381218824
Email
egaiffe@chu-besancon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Cecile Courivaud, MD, PhD
Email
ccourivaud@chu-besancon.fr
Facility Information:
Facility Name
Service de néphrologie, CHU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile COURIVAUD, Doctor
Email
ccourivaud@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Ingrid TISSOT
Email
itissot@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
COURIVAUD Cécile, Doctor
First Name & Middle Initial & Last Name & Degree
Didier DUCLOUX, Prof
First Name & Middle Initial & Last Name & Degree
Jamal BAMOULID, Doctor
First Name & Middle Initial & Last Name & Degree
Thomas CREPIN, Doctor
First Name & Middle Initial & Last Name & Degree
Jean-Marc CHALOPIN, Prof
First Name & Middle Initial & Last Name & Degree
Catherine BRESSON-VAUTRIN, Doctor
First Name & Middle Initial & Last Name & Degree
Caroline ROUBIOU, Doctor
Facility Name
Besancon University Hospital
City
Besançon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie Gaiffe, Dr.
First Name & Middle Initial & Last Name & Degree
Cecile Courivaud, Dr.

12. IPD Sharing Statement

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Occurrence of Emerging Infections After Placement of a Peritoneal Dialysis CatHeter

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