Peritonitis Prevention After Insertion of Peritoneal Dial... | NCT03046511

Studies
Peritonitis Prevention After Insertion of Peritoneal Dialysis Catheter.

NCT03046511

Sponsor

Carmel Medical Center

Status

Unknown status

Last Update Posted

Feb 13, 2023Actual

Enrollment

200Estimated

Phase

Phase 3

Conditions

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

Interventions

Cefazolin

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 8, 2017Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Feb 5, 2017

First Submission Date that Met QC Criteria

Feb 5, 2017

First Posted Date

Feb 8, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2023

Last Update Posted Date

Feb 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Victor Frajewicki, MD, Head, Department of Nephrology and Hypertension, Carmel Medical CenterPrincipal Investigator

Lead Sponsor

Carmel Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intraperitoneal	Experimental	One single dose of intraperitoneal Cefazolin 1000 mg via the recently inserted peritoneal catheter	Drug: Cefazolin
Intravenous	Active Comparator	One single dose of intravenous Cefazolin 1000 mg one hour before catheter insertion	Drug: Cefazolin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cefazolin	Drug	A post- procedure administration of Cefazolin will be compared with a pre-operative intravenous dose	Intraperitoneal Intravenous

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peritonitis	Peritonitis asscociated catheter defined by cloudy effluent, high leukocyte count with neutrofilia	14 days

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Victor Frajewicki, MD	Contact	972-4-8250491		vfraje@clalit.org.il

Overall Officials

Name	Affiliation	Role
Victor Frajewicki, MD	Carmel Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carmel Medical Center	Recruiting	Haifa		34362	Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002437	Cefazolin

Ancestor Terms

ID	Term
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930

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Browse Branches

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