Peritonitis Prevention After Insertion of Peritoneal Dialysis Catheter.

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: Cefazolin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraperitoneal<br>One single dose of intraperitoneal Cefazolin 1000 mg via the recently inserted peritoneal catheter | Drug: Cefazolin<br>* A post- procedure administration of Cefazolin will be compared with a pre-operative intravenous dose<br>|
| Active Comparator: Intravenous<br>One single dose of intravenous Cefazolin 1000 mg one hour before catheter insertion | Drug: Cefazolin<br>* A post- procedure administration of Cefazolin will be compared with a pre-operative intravenous dose<br>|

What is the study measuring?
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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 |