Pharmacological Study of Cefazolin Antibioprophylaxis in Liver Transplantation
- Conditions
- Surgical Site InfectionAntibiotic ProphylaxisCephazolin Adverse ReactionLiver Transplant Infection
- Interventions
- Other: Blood samples
- Registration Number
- NCT04280237
- Lead Sponsor
- University Hospital, Tours
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Age over 18
- patient undergoing liver transplantation
- receiving Cefazolin as perioperative antibiotic prophylaxis to prevent surgical site infections
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cefazolin in liver transplantation Blood samples Patient undergoing liver transplant surgery and receiving antibiotic prophylaxis with Cefazolin
- Primary Outcome Measures
Name Time Method Cefazolin blood concentration Baseline up to 10 hours Cefazolin blood concentration will be measured at the moment of surgical incision and every hour until end of surgery
- Secondary Outcome Measures
Name Time Method Assess correlations between Cefazolin blood concentration and Cirrhosis etiology baseline Cause of cirrhosis
Assess correlations between Cefazolin blood concentration and Blood loss End of surgery Blood loss quantification will be done throughout surgery
Assess correlations between Cefazolin blood concentration and CHILD-PUGH score baseline Patient's CHILD-PUGH score before transplantation
Assess correlations between Cefazolin blood concentration and Hemodialysis baseline Patient needing hemodialysis before liver transplantation
Assess correlations between Cefazolin blood concentration and MELD score baseline Patient's MELD score before transplantation
Assess correlations between Cefazolin blood concentration and Transplantation indication baseline Cause leading to transplantation
Assess correlations between Cefazolin blood concentration and Ascitis Baseline Volume of ascitis drained at the beginning of surgery
Assess correlations between Cefazolin blood concentration and Urine output End of surgery Volume of urine output during surgery
Assess correlations between Cefazolin blood concentration and Red cell transfusion unit End of surgery The number of red cell units transfused during transplantation will be counted at the end of surgery
Assess correlations between Cefazolin blood concentration and Plasma transfusion unit End of surgery The number of plasma units transfused during transplantation will be counted at the end of surgery
Assess correlations between Cefazolin blood concentration and Colloid infusion End of surgery Volume of colloid infusion during surgery
Assess correlations between Cefazolin blood concentration and Portal vein clamping time End of surgery Time of portal vein clamping and declamping during realization of vascular anastomosis will be noted
Assess correlations between Cefazolin blood concentration and Intraoperative blood salvage End of surgery Intraoperative blood salvage transfusion volume during surgery
Assess correlations between Cefazolin blood concentration and Surgical site infection Day 28 Number of patient with surgical site infection in the 28 days post-surgery
Assess correlations between Cefazolin blood concentration and Transjugular intrahepatic portosystemic shunt (TIPS) baseline Medical history of TIPS
Assess correlations between Cefazolin blood concentration and Creatinine baseline Creatinine levels will be measured before transplantation
Assess correlations between Cefazolin blood concentration and Surgery duration End of surgery Time of surgical incision and end of the surgery will be noted
Assess correlations between Cefazolin blood concentration and Crystalloid infusion End of surgery Assess correlations between Cefazolin blood concentration and Volume of crystalloid infusion during surgery
Assess correlations between Cefazolin blood concentration and Basal cardiac index Baseline Cardiac index value at the beginning of surgery
Assess correlations between Cefazolin blood concentration and Minimal cardiac index End of surgery Minimal index value during surgery
Assess correlations between Cefazolin blood concentration and Albumin baseline Albumin levels will be measured before transplantation
Assess correlations between Cefazolin blood concentration and Platelet transfusion unit End of surgery The number of platelet units transfused during transplantation will be counted at the end of surgery
Trial Locations
- Locations (1)
Surgical intensive care unit, University Hospital, Tours
🇫🇷Tours, France