Pharmacological Study of Cefazolin Antibioprophylaxis in Liver Transplantation

NCT ID: NCT04280237

Last Updated: 2021-04-29

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-31

Study Completion Date

2020-03-18

Brief Summary

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This study describes Cefazolin pharmacokinetics variation to target levels during liver transplantation.

Detailed Description

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Cefazolin is one of the many drugs used in antibiotic prophylaxis during liver transplantation. However there are no study describing its pharmacokinetics during liver transplantation.

Due to the severe pharmacokinetics interactions caused by both prior hepatopathy and surgical techniques we suppose that Cefazolin blood levels are very different from those targeted for antibiotic prophylaxis.

This study aim to describe pharmacokinetics of Cefazolin during liver transplantation in order to adapt antibiotic prophylaxis strategy in case of unadapted measured levels.

Conditions

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Liver Transplant Infection Surgical Site Infection Antibiotic Prophylaxis Cephazolin Adverse Reaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cefazolin in liver transplantation

Patient undergoing liver transplant surgery and receiving antibiotic prophylaxis with Cefazolin

Blood samples

Intervention Type OTHER

Blood samples

Interventions

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Blood samples

Blood samples

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age over 18
* patient undergoing liver transplantation
* receiving Cefazolin as perioperative antibiotic prophylaxis to prevent surgical site infections

Exclusion Criteria

* pregnant women
* legal protection or protected adults
* ongoing antibiotic treatment before liver transplantation
* patient inability to receive information or express opposition to the study.
* patient refusing participation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-Charlotte TELLIER, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Tours

Locations

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Surgical intensive care unit, University Hospital, Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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2020-A00405-34

Identifier Type: OTHER

Identifier Source: secondary_id

RIPH3-RNI20/ProCeTH

Identifier Type: -

Identifier Source: org_study_id

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