Clinical trial NCT04730830: Occurrence of Emerging Infections After Placement of a Peritoneal Dialysis CatHeter
Official title: Survenue Des Infections d'Emergence après la Pose d'un catHéter de Dialyse péritonéaLE
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Renal Disease on Dialysis
Peritoneal Dialysis
Keywords: Renal disease
Peritoneal dialysis
Emergence infections
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Observational study with questionnaires
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Risk of infections on emergence site
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Service de néphrologie, CHU de Besançon
city: Besançon
country: France
facility: Besancon University Hospital
Study officials:
References: