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Peritonitis Prevention After Insertion of Peritoneal Dialysis Catheter.

NCT ID: NCT03046511

Last Updated: 2023-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-08

Study Completion Date

2023-12-31

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Intraperitoneal

One single dose of intraperitoneal Cefazolin 1000 mg via the recently inserted peritoneal catheter

Group Type EXPERIMENTAL

Cefazolin

Intervention Type DRUG

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

Intravenous

One single dose of intravenous Cefazolin 1000 mg one hour before catheter insertion

Group Type ACTIVE_COMPARATOR

Cefazolin

Intervention Type DRUG

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

Interventions

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Cefazolin

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carmel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Victor Frajewicki, MD

Head, Department of Nephrology and Hypertension

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Victor Frajewicki, MD

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center

Locations

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Carmel Medical Center

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Victor Frajewicki, MD

Role: CONTACT

[email protected]
972-4-8250491

Facility Contacts

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Victor Frajewicki, MD

Role: primary

[email protected]
+97248250491

Tatiana Tanasiychuk, MD

Role: backup

[email protected]
+97248250954

Other Identifiers

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CMC-16-0067-CTIL

Identifier Type: -

Identifier Source: org_study_id

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