Pharmacological Study of Cefazolin Antibioprophylaxis in Liver Transplantation

NCT04280237 | Withdrawn

• 2 other identifiers: RIPH3-RNI20/ProCeTH2020-A00405-34
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Transplant Infection; Surgical Site Infection; Antibiotic Prophylaxis; Cephazolin Adverse Reaction

Keywords

antibiotic prophylaxis; liver transplant; surgical site infection; Cefazolin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Assess correlations between Cefazolin blood concentration and CHILD-PUGH score

  baseline

• Assess correlations between Cefazolin blood concentration and MELD score

  baseline

• Assess correlations between Cefazolin blood concentration and Cirrhosis etiology

  baseline

• Assess correlations between Cefazolin blood concentration and Transplantation indication

  baseline

• Assess correlations between Cefazolin blood concentration and Transjugular intrahepatic portosystemic shunt (TIPS)

  baseline

Study Arms (1)

Cefazolin in liver transplantation

Patient undergoing liver transplant surgery and receiving antibiotic prophylaxis with Cefazolin

Other: Blood samples

Interventions

Blood samples OTHER

Blood samples

Cefazolin in liver transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patient receiving Cefazolin as perioperative antibiotic prophylaxis during liver transplantation.

You may qualify if:

• Age over 18
• patient undergoing liver transplantation
• receiving Cefazolin as perioperative antibiotic prophylaxis to prevent surgical site infections

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

Surgical intensive care unit, University Hospital, Tours

Tours, 37044, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Anne-Charlotte TELLIER, MD

  University Hospital, Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 21, 2020
• Study Start: March 1, 2020
• Primary Completion: March 18, 2020
• Study Completion: March 18, 2020
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

FR (1)