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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Tours

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 18, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 18, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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