Clinical trial NCT04280237: Pharmacological Study of Cefazolin Antibioprophylaxis in Liver Transplantation
Official title: Pharmacological Study of Cefazolin Antibioprophylaxis in Liver Transplantation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Liver Transplant Infection
Surgical Site Infection
Antibiotic Prophylaxis
Cephazolin Adverse Reaction
Keywords: antibiotic prophylaxis
liver transplant
surgical site infection
Cefazolin
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient receiving Cefazolin as perioperative antibiotic prophylaxis during liver transplantation.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cefazolin blood concentration
timeFrame: Baseline up to 10 hours
Secondary outcomes:
measure: Assess correlations between Cefazolin blood concentration and CHILD-PUGH score
timeFrame: baseline
measure: Assess correlations between Cefazolin blood concentration and MELD score
timeFrame: baseline
measure: Assess correlations between Cefazolin blood concentration and Cirrhosis etiology
timeFrame: baseline
measure: Assess correlations between Cefazolin blood concentration and Transplantation indication
timeFrame: baseline
measure: Assess correlations between Cefazolin blood concentration and Transjugular intrahepatic portosystemic shunt (TIPS)
timeFrame: baseline
measure: Assess correlations between Cefazolin blood concentration and Creatinine
timeFrame: baseline
measure: Assess correlations between Cefazolin blood concentration and Hemodialysis
timeFrame: baseline
measure: Assess correlations between Cefazolin blood concentration and Albumin
timeFrame: baseline
measure: Assess correlations between Cefazolin blood concentration and Surgery duration
timeFrame: End of surgery
measure: Assess correlations between Cefazolin blood concentration and Portal vein clamping time
timeFrame: End of surgery
measure: Assess correlations between Cefazolin blood concentration and Ascitis
timeFrame: Baseline
measure: Assess correlations between Cefazolin blood concentration and Urine output
timeFrame: End of surgery
measure: Assess correlations between Cefazolin blood concentration and Blood loss
timeFrame: End of surgery
measure: Assess correlations between Cefazolin blood concentration and Red cell transfusion unit
timeFrame: End of surgery
measure: Assess correlations between Cefazolin blood concentration and Platelet transfusion unit
timeFrame: End of surgery
measure: Assess correlations between Cefazolin blood concentration and Plasma transfusion unit
timeFrame: End of surgery
measure: Assess correlations between Cefazolin blood concentration and Intraoperative blood salvage
timeFrame: End of surgery
measure: Assess correlations between Cefazolin blood concentration and Crystalloid infusion
timeFrame: End of surgery
measure: Assess correlations between Cefazolin blood concentration and Colloid infusion
timeFrame: End of surgery
measure: Assess correlations between Cefazolin blood concentration and Basal cardiac index
timeFrame: Baseline
measure: Assess correlations between Cefazolin blood concentration and Minimal cardiac index
timeFrame: End of surgery
measure: Assess correlations between Cefazolin blood concentration and Surgical site infection
timeFrame: Day 28
Other outcomes:
Locations:
city: Tours
country: France
facility: Surgical intensive care unit, University Hospital, Tours
Study officials:
affiliation: University Hospital, Tours
name: Anne-Charlotte TELLIER, MD
role: PRINCIPAL_INVESTIGATOR
References: