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
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
One single dose of intraperitoneal Cefazolin 1000 mg via the recently inserted peritoneal catheter
Intervention: Cefazolin (Drug)
Intravenous
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
Victor Frajewicki, MD
Head, Department of Nephrology and Hypertension
Carmel Medical Center