Peritonitis Prevention After Insertion of Peritoneal Dialysis Catheter.

Peritoneal Dialysis Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03046511
• Other study ID #: CMC-16-0067-CTIL
• Status: Recruiting
• Phase: Phase 3
• Start date: March 8, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Carmel Medical Center
• Contact: Victor Frajewicki, MD
• Phone: 972-4-8250491
• Email: vfraje[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peritonitis	Peritonitis asscociated catheter defined by cloudy effluent, high leukocyte count with neutrofilia	14 days
Secondary	Exit site infection	Infection defined by purulent discharge or local redness	14 days
Secondary	Tunnel infection	Inflammation in the subcutaneous tract of the peritoneal catheter	14 days