Back to resultsPeritonitis Prevention After Insertion of Peritoneal Dialysis Catheter.
Primary Purpose
Peritoneal Dialysis-associated Peritonitis, Peritoneal Dialysis Catheter Infection, Peritoneal Dialysis Complication
Status
Recruiting
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Cefazolin
Sponsored by
About this trial
This is an interventional prevention trial for Peritoneal Dialysis-associated Peritonitis
Eligibility Criteria
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
Sites / Locations
- Carmel Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intraperitoneal
Intravenous
Arm Description
One single dose of intraperitoneal Cefazolin 1000 mg via the recently inserted peritoneal catheter
One single dose of intravenous Cefazolin 1000 mg one hour before catheter insertion
Outcomes
Primary Outcome Measures
Peritonitis
Peritonitis asscociated catheter defined by cloudy effluent, high leukocyte count with neutrofilia
Secondary Outcome Measures
Exit site infection
Infection defined by purulent discharge or local redness
Tunnel infection
Inflammation in the subcutaneous tract of the peritoneal catheter
Full Information
NCT ID
NCT03046511
First Posted
February 5, 2017
Last Updated
February 8, 2023
Sponsor
Carmel Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03046511
Brief Title
Peritonitis Prevention After Insertion of Peritoneal Dialysis Catheter.
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2017 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carmel Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Dialysis-associated Peritonitis, Peritoneal Dialysis Catheter Infection, Peritoneal Dialysis Complication
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intraperitoneal
Arm Type
Experimental
Arm Description
One single dose of intraperitoneal Cefazolin 1000 mg via the recently inserted peritoneal catheter
Arm Title
Intravenous
Arm Type
Active Comparator
Arm Description
One single dose of intravenous Cefazolin 1000 mg one hour before catheter insertion
Intervention Type
Drug
Intervention Name(s)
Cefazolin
Intervention Description
A post- procedure administration of Cefazolin will be compared with a pre-operative intravenous dose
Primary Outcome Measure Information:
Title
Peritonitis
Description
Peritonitis asscociated catheter defined by cloudy effluent, high leukocyte count with neutrofilia
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Exit site infection
Description
Infection defined by purulent discharge or local redness
Time Frame
14 days
Title
Tunnel infection
Description
Inflammation in the subcutaneous tract of the peritoneal catheter
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victor Frajewicki, MD
Phone
972-4-8250491
Email
vfraje@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Frajewicki, MD
Organizational Affiliation
Carmel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Frajewicki, MD
Phone
+97248250491
Email
vfraje@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Tatiana Tanasiychuk, MD
Phone
+97248250954
Email
TatianaTa1@clalit.org.il
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Peritonitis Prevention After Insertion of Peritoneal Dialysis Catheter.
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