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
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2017
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2017
CompletedFirst Posted
Study publicly available on registry
February 8, 2017
CompletedStudy Start
First participant enrolled
March 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedFebruary 13, 2023
February 1, 2023
6.8 years
February 5, 2017
February 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Peritonitis
Peritonitis asscociated catheter defined by cloudy effluent, high leukocyte count with neutrofilia
14 days
Secondary Outcomes (2)
Exit site infection
14 days
Tunnel infection
14 days
Study Arms (2)
Intraperitoneal
EXPERIMENTALOne single dose of intraperitoneal Cefazolin 1000 mg via the recently inserted peritoneal catheter
Intravenous
ACTIVE COMPARATOROne single dose of intravenous Cefazolin 1000 mg one hour before catheter insertion
Interventions
A post- procedure administration of Cefazolin will be compared with a pre-operative intravenous dose
Eligibility Criteria
You may qualify if:
- Subjects suffering from Chronic Kidney Disease, candidates to a intra- peritoneal catheter insertion
You may not qualify if:
- Pregnancy; Active antibiotic treatment before the procedure; Known allergy to Cefazolin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carmel Medical Center
Haifa, 34362, Israel
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victor Frajewicki, MD
Carmel Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head, Department of Nephrology and Hypertension
Study Record Dates
First Submitted
February 5, 2017
First Posted
February 8, 2017
Study Start
March 8, 2017
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
February 13, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share