Peritonitis Prevention After Insertion of Peritoneal Dialysis Catheter.

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03046511

Enrollment

200

Registered

2017-02-08

Start date

2017-03-08

Completion date

2023-12-31

Last updated

2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal Dialysis-associated Peritonitis, Peritoneal Dialysis Catheter Infection, Peritoneal Dialysis Complication

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.

Interventions

DRUGCefazolin

A post- procedure administration of Cefazolin will be compared with a pre-operative intravenous dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Peritonitis	14 days	Peritonitis asscociated catheter defined by cloudy effluent, high leukocyte count with neutrofilia

Secondary

Measure	Time frame	Description
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

Countries

Israel

Contacts

Primary ContactVictor Frajewicki, MD

vfraje@clalit.org.il972-4-8250491

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026