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

C

Centre Hospitalier Universitaire de Besancon

Status

Enrolling

Conditions

Peritoneal Dialysis
End Stage Renal Disease on Dialysis

Treatments

Other: Questionnaire

Study type

Interventional

Funder types

Other

Identifiers

NCT04730830
2020/504

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Only experimental arm
Experimental group
Description:
Only experimental arm. Patients filling out questionnaires.
Treatment:
Other: Questionnaire

Trial contacts and locations

2

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Central trial contact

Emilie Gaiffe, PhD; Cecile Courivaud, MD, PhD

Data sourced from clinicaltrials.gov

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