ProCeTH: Pharmacological Study of Cefazolin Antibioprophylaxis in Liver Transplantation
Study Details
Study Description
Brief Summary
This study describes Cefazolin pharmacokinetics variation to target levels during liver transplantation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cefazolin in liver transplantation Patient undergoing liver transplant surgery and receiving antibiotic prophylaxis with Cefazolin |
Other: Blood samples
Blood samples
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 MELD score [baseline]
Patient's MELD score before transplantation
- Assess correlations between Cefazolin blood concentration and Cirrhosis etiology [baseline]
Cause of cirrhosis
- Assess correlations between Cefazolin blood concentration and Transplantation indication [baseline]
Cause leading to transplantation
- 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 Hemodialysis [baseline]
Patient needing hemodialysis before liver transplantation
- Assess correlations between Cefazolin blood concentration and Albumin [baseline]
Albumin 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 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 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 Blood loss [End of surgery]
Blood loss quantification will be done throughout 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 Platelet transfusion unit [End of surgery]
The number of platelet 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 Intraoperative blood salvage [End of surgery]
Intraoperative blood salvage transfusion volume during surgery
- 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 Colloid infusion [End of surgery]
Volume of colloid 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 Surgical site infection [Day 28]
Number of patient with surgical site infection in the 28 days post-surgery
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Surgical intensive care unit, University Hospital, Tours | Tours | France | 37044 |
Sponsors and Collaborators
- University Hospital, Tours
Investigators
- Principal Investigator: Anne-Charlotte TELLIER, MD, University Hospital, Tours
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RIPH3-RNI20/ProCeTH
- 2020-A00405-34