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Clinical Trials/NCT03046511
NCT03046511RecruitingPhase 3

Comparison Between Post - Surgical Intraperitoneal Antibiotics Administration Vs. Intravenous Pre- Surgical Administration for the Prevention of Peritonitis After Insertion of Peritoneal Dialysis Catheter in Peritoneal Dialysis Patients

Carmel Medical Center1 site in 1 country200 target enrollmentStarted: March 8, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Sponsor
Enrollment
200
Locations
1
Primary Endpoint
Peritonitis

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Intraperitoneal

Experimental

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

Intervention: Cefazolin (Drug)

Intravenous

Active Comparator

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

Intervention: Cefazolin (Drug)

Outcomes

Primary Outcomes

Peritonitis

Time Frame: 14 days

Peritonitis asscociated catheter defined by cloudy effluent, high leukocyte count with neutrofilia

Secondary Outcomes

  • Exit site infection(14 days)
  • Tunnel infection(14 days)

Investigators

Sponsor
Carmel Medical Center
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Victor Frajewicki, MD

Head, Department of Nephrology and Hypertension

Carmel Medical Center

Study Sites (1)

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