Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics

University of Virginia

Status and phase: Completed; Phase 3

Conditions: Liver Transplantation; Surgical Site Infection

Treatments: Drug: extended; Other: liver transplant; Drug: standard

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02717273

T32AI078875 (U.S. NIH Grant/Contract)

IRB-HSR#14971

Details and patient eligibility

About

This study will be to prospectively determine differences in Surgical Site Infection (SSI) if a prolonged course of post-operative antibiotics are used following liver transplantation.

Full description

This study will be to prospectively determine differences in SSI if a prolonged course of post-operative antibiotics are used following liver transplantation. All adult patients, admitted to the University of Virginia (UVA) Medical Center for first-time liver transplantation will be randomized to the standard of care of peri-operative antibiotics or extended course of three total days.

Patients will be evaluated primarily for the presence of post-operative surgical site infections but also for fever, elevated white blood counts, secondary infections (urinary tract, pneumonia, and blood stream), length of hospital stay, graft loss, and mortality for 30 days after liver transplant.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients ≥ 18 years of age.
• Eligible for liver transplantation by UVA standard protocol.
• First-time transplantation.
• No active infections - requiring antibiotics - excluding antifungals.

Exclusion criteria

• All patients < 18 years of age.
• Previous liver transplantation.
• Active infections - requiring antibiotics.
• Allergy to all standard peri-operative antibiotics (piperacillin/tazobactam or UVA standard alternatives for Penicillin allergic patients: ciprofloxacin and vancomycin).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

102 participants in 2 patient groups

standard peri-operative antibiotics

Active Comparator group

Description:

The standard of care at the University of Virginia Medical Center for liver transplantation patients is a 3.375 gram dose of piperacillin / tazobactam (Zosyn®) at the time of induction of anesthesia, though this dose may be adjusted for renal insufficiency. This dose is repeated during the operation every six hours.

Treatment:

Drug: standard

Other: liver transplant

extended three-day course of antibiotics

Experimental group

Description:

For those patients randomized to the study group, antibiotics will be started as per the usual intra-operative dosing regimen, then continued to provide coverage for 72 hours. This is typically provided as additional doses of 3.375 grams of piperacillin / tazobactam (Zosyn®) every 8 hours for 3 total days (giving a total of 72 hours of antibiotic coverage), though this may be altered based on kidney function.

Treatment:

Other: liver transplant

Drug: extended