Pharmacological Study of Cefazolin Antibioprophylaxis in Liver Transplantation

Surgical Site Infection Clinical Trial

— ProCeTH  

Official title:

Pharmacological Study of Cefazolin Antibioprophylaxis in Liver Transplantation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04280237
• Other study ID #: RIPH3-RNI20/ProCeTH
• Secondary ID: 2020-A00405-34
• Status: Withdrawn
• Start date: March 2020
• Est. completion date: March 18, 2020

Study information

• Verified date: April 2021
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 18, 2020
• Est. primary completion date: March 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Prophylaxis
• Cephazolin Adverse Reaction
• Communicable Diseases
• Infection
• Liver Transplant Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Other:
• Blood samples
Blood samples

Locations

Country	Name	City	State
France	Surgical intensive care unit, University Hospital, Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assess correlations between Cefazolin blood concentration and CHILD-PUGH score	Patient's CHILD-PUGH score before transplantation	baseline
Secondary	Assess correlations between Cefazolin blood concentration and MELD score	Patient's MELD score before transplantation	baseline
Secondary	Assess correlations between Cefazolin blood concentration and Cirrhosis etiology	Cause of cirrhosis	baseline
Secondary	Assess correlations between Cefazolin blood concentration and Transplantation indication	Cause leading to transplantation	baseline
Secondary	Assess correlations between Cefazolin blood concentration and Transjugular intrahepatic portosystemic shunt (TIPS)	Medical history of TIPS	baseline
Secondary	Assess correlations between Cefazolin blood concentration and Creatinine	Creatinine levels will be measured before transplantation	baseline
Secondary	Assess correlations between Cefazolin blood concentration and Hemodialysis	Patient needing hemodialysis before liver transplantation	baseline
Secondary	Assess correlations between Cefazolin blood concentration and Albumin	Albumin levels will be measured before transplantation	baseline
Secondary	Assess correlations between Cefazolin blood concentration and Surgery duration	Time of surgical incision and end of the surgery will be noted	End of surgery
Secondary	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
Secondary	Assess correlations between Cefazolin blood concentration and Ascitis	Volume of ascitis drained at the beginning of surgery	Baseline
Secondary	Assess correlations between Cefazolin blood concentration and Urine output	Volume of urine output during surgery	End of surgery
Secondary	Assess correlations between Cefazolin blood concentration and Blood loss	Blood loss quantification will be done throughout surgery	End of surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Assess correlations between Cefazolin blood concentration and Intraoperative blood salvage	Intraoperative blood salvage transfusion volume during surgery	End of surgery
Secondary	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
Secondary	Assess correlations between Cefazolin blood concentration and Colloid infusion	Volume of colloid infusion during surgery	End of surgery
Secondary	Assess correlations between Cefazolin blood concentration and Basal cardiac index	Cardiac index value at the beginning of surgery	Baseline
Secondary	Assess correlations between Cefazolin blood concentration and Minimal cardiac index	Minimal index value during surgery	End of surgery
Secondary	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