Pharmacological Study of Cefazolin Antibioprophylaxis in Liver Transplantation (ProCeTH)

April 27, 2021 updated by: University Hospital, Tours
This study describes Cefazolin pharmacokinetics variation to target levels during liver transplantation.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tours, France, 37044
        • Surgical Intensive Care Unit, University Hospital, Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patient receiving Cefazolin as perioperative antibiotic prophylaxis during liver transplantation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cefazolin in liver transplantation
Patient undergoing liver transplant surgery and receiving antibiotic prophylaxis with Cefazolin
Other: Blood samples
Blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cefazolin blood concentration
Time Frame: Baseline up to 10 hours
Cefazolin blood concentration will be measured at the moment of surgical incision and every hour until end of surgery
Baseline up to 10 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess correlations between Cefazolin blood concentration and CHILD-PUGH score
Time Frame: baseline
Patient's CHILD-PUGH score before transplantation
baseline
Assess correlations between Cefazolin blood concentration and MELD score
Time Frame: baseline
Patient's MELD score before transplantation
baseline
Assess correlations between Cefazolin blood concentration and Cirrhosis etiology
Time Frame: baseline
Cause of cirrhosis
baseline
Assess correlations between Cefazolin blood concentration and Transplantation indication
Time Frame: baseline
Cause leading to transplantation
baseline
Assess correlations between Cefazolin blood concentration and Transjugular intrahepatic portosystemic shunt (TIPS)
Time Frame: baseline
Medical history of TIPS
baseline
Assess correlations between Cefazolin blood concentration and Creatinine
Time Frame: baseline
Creatinine levels will be measured before transplantation
baseline
Assess correlations between Cefazolin blood concentration and Hemodialysis
Time Frame: baseline
Patient needing hemodialysis before liver transplantation
baseline
Assess correlations between Cefazolin blood concentration and Albumin
Time Frame: baseline
Albumin levels will be measured before transplantation
baseline
Assess correlations between Cefazolin blood concentration and Surgery duration
Time Frame: End of surgery
Time of surgical incision and end of the surgery will be noted
End of surgery
Assess correlations between Cefazolin blood concentration and Portal vein clamping time
Time Frame: End of surgery
Time of portal vein clamping and declamping during realization of vascular anastomosis will be noted
End of surgery
Assess correlations between Cefazolin blood concentration and Ascitis
Time Frame: Baseline
Volume of ascitis drained at the beginning of surgery
Baseline
Assess correlations between Cefazolin blood concentration and Urine output
Time Frame: End of surgery
Volume of urine output during surgery
End of surgery
Assess correlations between Cefazolin blood concentration and Blood loss
Time Frame: End of surgery
Blood loss quantification will be done throughout surgery
End of surgery
Assess correlations between Cefazolin blood concentration and Red cell transfusion unit
Time Frame: End of surgery
The number of red cell units transfused during transplantation will be counted at the end of surgery
End of surgery
Assess correlations between Cefazolin blood concentration and Platelet transfusion unit
Time Frame: End of surgery
The number of platelet units transfused during transplantation will be counted at the end of surgery
End of surgery
Assess correlations between Cefazolin blood concentration and Plasma transfusion unit
Time Frame: End of surgery
The number of plasma units transfused during transplantation will be counted at the end of surgery
End of surgery
Assess correlations between Cefazolin blood concentration and Intraoperative blood salvage
Time Frame: End of surgery
Intraoperative blood salvage transfusion volume during surgery
End of surgery
Assess correlations between Cefazolin blood concentration and Crystalloid infusion
Time Frame: End of surgery
Assess correlations between Cefazolin blood concentration and Volume of crystalloid infusion during surgery
End of surgery
Assess correlations between Cefazolin blood concentration and Colloid infusion
Time Frame: End of surgery
Volume of colloid infusion during surgery
End of surgery
Assess correlations between Cefazolin blood concentration and Basal cardiac index
Time Frame: Baseline
Cardiac index value at the beginning of surgery
Baseline
Assess correlations between Cefazolin blood concentration and Minimal cardiac index
Time Frame: End of surgery
Minimal index value during surgery
End of surgery
Assess correlations between Cefazolin blood concentration and Surgical site infection
Time Frame: Day 28
Number of patient with surgical site infection in the 28 days post-surgery
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Principal Investigator: Anne-Charlotte TELLIER, MD, University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2020

Primary Completion (Actual)

March 18, 2020

Study Completion (Actual)

March 18, 2020

Study Registration Dates

First Submitted

February 18, 2020

First Submitted That Met QC Criteria

February 20, 2020

First Posted (Actual)

February 21, 2020

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIPH3-RNI20/ProCeTH
  • 2020-A00405-34 (Other Identifier: IdRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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