Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Liver Transplantation Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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standard peri-operative antibiotics

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.

Group Type ACTIVE_COMPARATOR

standard

Intervention Type DRUG

peri-operative antibiotic regimen only

liver transplant

Intervention Type OTHER

orthotopic liver transplantation

extended three-day course of antibiotics

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.

Group Type EXPERIMENTAL

extended

Intervention Type DRUG

extended three-day course of antibiotics

liver transplant

Intervention Type OTHER

orthotopic liver transplantation

Interventions

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standard

peri-operative antibiotic regimen only

Intervention Type DRUG

extended

extended three-day course of antibiotics

Intervention Type DRUG

liver transplant

orthotopic liver transplantation

Intervention Type OTHER

Other Intervention Names

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Peri-operative only antibiotics Extended, three-day antibiotics

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No