Pharmacological Study of Cefazolin Antibioprophylaxis in Liver Transplantation

Study Overview
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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.

Official Title
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Pharmacological Study of Cefazolin Antibioprophylaxis in Liver Transplantation

Conditions
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Liver Transplant Infection, Surgical Site Infection, Antibiotic Prophylaxis, Cephazolin Adverse Reaction

Intervention / Treatment
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* Other: Blood samples


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cefazolin in liver transplantation<br>Patient undergoing liver transplant surgery and receiving antibiotic prophylaxis with Cefazolin | Other: Blood samples<br>* Blood samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cefazolin blood concentration | 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 | Patient's CHILD-PUGH score before transplantation | baseline | 
| Assess correlations between Cefazolin blood concentration and MELD score | Patient's MELD score before transplantation | baseline | 
| Assess correlations between Cefazolin blood concentration and Cirrhosis etiology | Cause of cirrhosis | baseline | 
| Assess correlations between Cefazolin blood concentration and Transplantation indication | Cause leading to transplantation | baseline | 
| Assess correlations between Cefazolin blood concentration and Transjugular intrahepatic portosystemic shunt (TIPS) | Medical history of TIPS | baseline | 
| Assess correlations between Cefazolin blood concentration and Creatinine | Creatinine levels will be measured before transplantation | baseline | 
| Assess correlations between Cefazolin blood concentration and Hemodialysis | Patient needing hemodialysis before liver transplantation | baseline | 
| Assess correlations between Cefazolin blood concentration and Albumin | Albumin levels will be measured before transplantation | baseline | 
| Assess correlations between Cefazolin blood concentration and Surgery duration | 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 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 | Volume of ascitis drained at the beginning of surgery | Baseline | 
| Assess correlations between Cefazolin blood concentration and Urine output | Volume of urine output during surgery | End of surgery | 
| Assess correlations between Cefazolin blood concentration and Blood loss | Blood loss quantification will be done throughout surgery | End of surgery | 
| Assess correlations between Cefazolin blood concentration and Red cell transfusion unit | 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 | 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 | 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 | Intraoperative blood salvage transfusion volume during surgery | End of surgery | 
| Assess correlations between Cefazolin blood concentration and Crystalloid infusion | 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 | Volume of colloid infusion during surgery | End of surgery | 
| Assess correlations between Cefazolin blood concentration and Basal cardiac index | Cardiac index value at the beginning of surgery | Baseline | 
| Assess correlations between Cefazolin blood concentration and Minimal cardiac index | Minimal index value during surgery | End of surgery | 
| Assess correlations between Cefazolin blood concentration and Surgical site infection | Number of patient with surgical site infection in the 28 days post-surgery | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antibiotic prophylaxis, liver transplant, surgical site infection, Cefazolin