Peritonitis Prevention After Insertion of Peritoneal Dialysis Catheter.

Phase 3

Recruiting

• Conditions: Peritoneal Dialysis Complication; Peritoneal Dialysis Catheter Infection; Peritoneal Dialysis-associated Peritonitis
• Interventions: Drug: Cefazolin

• Registration Number: NCT03046511
• Lead Sponsor: Carmel Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-05
• Study First Submitted QC: 2017-02-05
• Study First Posted: 2017-02-08
• Study Start: 2017-03-08
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-13
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraperitoneal	Cefazolin	One single dose of intraperitoneal Cefazolin 1000 mg via the recently inserted peritoneal catheter
Intravenous	Cefazolin	One single dose of intravenous Cefazolin 1000 mg one hour before catheter insertion

Primary Outcome Measures

Name	Time	Method
Peritonitis	14 days	Peritonitis asscociated catheter defined by cloudy effluent, high leukocyte count with neutrofilia

Secondary Outcome Measures

Name	Time	Method
Exit site infection	14 days	Infection defined by purulent discharge or local redness
Tunnel infection	14 days	Inflammation in the subcutaneous tract of the peritoneal catheter

Trial Locations

Locations (1)

Carmel Medical Center; 🇮🇱 Haifa, Israel