Occurrence of Emerging Infections After Placement of a Peritoneal Dialysis CatHeter

NCT04730830 | Unknown

• 1 other identifier: 2020/504
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

End Stage Renal Disease on Dialysis; Peritoneal Dialysis

Keywords

Renal disease; Peritoneal dialysis; Emergence infections

Outcome Measures

Primary Outcomes (1)

• 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 .

  24 months

Study Arms (1)

Only experimental arm

EXPERIMENTAL

Only experimental arm. Patients filling out questionnaires.

Other: Questionnaire

Interventions

Questionnaire OTHER

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.

Only experimental arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Legal incapacity or limited legal capacity
• Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator
• Pregnant woman
• Patient without health insurance

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (2)

Service de néphrologie, CHU de Besançon

Besançon, 25000, France

RECRUITING

Besancon University Hospital

Besançon, 25030, France

RECRUITING

MeSH Terms

Conditions

Kidney Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Emilie Gaiffe, PhD

CONTACT

+33381218824; egaiffe@chu-besancon.fr

Cecile Courivaud, MD, PhD

CONTACT

ccourivaud@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Observational study with questionnaires

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 29, 2021
• Study Start: February 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: August 1, 2025
• Last Updated: August 2, 2022

Record last verified: 2022-07

Locations

FR (2)