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

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 Overview

• Status: Recruiting
• Conditions: Peritoneal Dialysis Catheter Infection; Peritoneal Dialysis-associated Peritonitis; Peritoneal Dialysis Complication
• Intervention / Treatment: Drug: Cefazolin

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Victor Frajewicki, MD; Phone Number: 972-4-8250491; Email: vfraje@clalit.org.il

Study Locations

• Israel
  • Haifa, Israel, 34362
    • Recruiting
    • Carmel Medical Center
    • Contact: Victor Frajewicki, MD; Phone Number: +97248250491; Email: vfraje@clalit.org.il
    • Contact: Tatiana Tanasiychuk, MD; Phone Number: +97248250954; Email: TatianaTa1@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intraperitoneal; One single dose of intraperitoneal Cefazolin 1000 mg via the recently inserted peritoneal catheter	Drug: Cefazolin; A post- procedure administration of Cefazolin will be compared with a pre-operative intravenous dose
ACTIVE_COMPARATOR: Intravenous; One single dose of intravenous Cefazolin 1000 mg one hour before catheter insertion	Drug: Cefazolin; A post- procedure administration of Cefazolin will be compared with a pre-operative intravenous dose

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exit site infection	Infection defined by purulent discharge or local redness	14 days
Tunnel infection	Inflammation in the subcutaneous tract of the peritoneal catheter	14 days

Collaborators and Investigators

• Sponsor: Carmel Medical Center
• Investigators: Principal Investigator: Victor Frajewicki, MD, Carmel Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 8, 2017
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: February 5, 2017
• First Submitted That Met QC Criteria: February 5, 2017
• First Posted (ESTIMATE): February 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Peritoneal Diseases; Intraabdominal Infections; Peritonitis; Anti-Infective Agents; Anti-Bacterial Agents; Cefazolin
• Other Study ID Numbers: CMC-16-0067-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No