Peritonitis Prevention After Insertion of Peritoneal Dialysis Catheter.

Israel Healthcare Foundation

Status and phase: Enrolling; Phase 3

Conditions: Peritoneal Dialysis Complication; Peritoneal Dialysis-associated Peritonitis; Peritoneal Dialysis Catheter Infection

Treatments: Drug: Cefazolin

Study type: Interventional

Funder types: Other

Identifiers

NCT03046511

CMC-16-0067-CTIL

Details and patient eligibility

About

An intraperitoneal implanted catheter is always necessary to perform Peritoneal Dialysis. Catheter insertion has been associated with infectious complication such as Exit Site Infection (ESI), Tunnel Infection and Peritonitis. The last one may lead to loss of the technique because the need of catheter removal. Most of international guidelines recommends the use of prophylactic antibiotics. Different protocols has been used, mostly intravenous single injection before the procedure. For the last 25 years our unit gives a single intraperitoneal dose of Cefazolin immediately after the catheter insertion. The aim of this study is compare the effect of a pre- operative IV dose os Cefazolin with a post- procedure intraperitoneal single dose administration of the same drug.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects suffering from Chronic Kidney Disease, candidates to a intra- peritoneal catheter insertion

Exclusion criteria

Pregnancy; Active antibiotic treatment before the procedure; Known allergy to Cefazolin

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 2 patient groups

Intraperitoneal

Experimental group

Description:

One single dose of intraperitoneal Cefazolin 1000 mg via the recently inserted peritoneal catheter

Treatment:

Drug: Cefazolin

Intravenous

Active Comparator group

Description:

One single dose of intravenous Cefazolin 1000 mg one hour before catheter insertion

Treatment:

Drug: Cefazolin