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

August 1, 2022 updated by: Centre Hospitalier Universitaire de Besancon

Survenue Des Infections d'Emergence après la Pose d'un catHéter de Dialyse péritonéaLE

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Besançon, France, 25030
        • Recruiting
        • Besançon University Hospital
        • Contact:
          • Emilie Gaiffe, Dr.
        • Principal Investigator:
          • Cecile Courivaud, Dr.
      • Besançon, France, 25000
        • Recruiting
        • Service de néphrologie, CHU de Besançon
        • Contact:
        • Contact:
        • Principal Investigator:
          • COURIVAUD Cécile, Doctor
        • Sub-Investigator:
          • Didier DUCLOUX, Prof
        • Sub-Investigator:
          • Jamal BAMOULID, Doctor
        • Sub-Investigator:
          • Thomas CREPIN, Doctor
        • Sub-Investigator:
          • Jean-Marc CHALOPIN, Prof
        • Sub-Investigator:
          • Catherine BRESSON-VAUTRIN, Doctor
        • Sub-Investigator:
          • Caroline ROUBIOU, Doctor

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Only experimental arm
Only experimental arm. Patients filling out questionnaires.
Other: Questionnaire
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Risk of infections on emergence site
Time Frame: 24 months
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 .
24 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Besancon

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020/504

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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