Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics

Phase 3

Completed

• Conditions: Liver Transplantation; Surgical Site Infection
• Interventions: Drug: standard; Drug: extended; Other: liver transplant

• Registration Number: NCT02717273
• Lead Sponsor: University of Virginia

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-22
• Study First Posted: 2016-03-23
• Results First Submitted: 2018-05-18
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-18
• Last Update Submitted: 2018-06-18
• Results First Posted: 2018-07-17
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard peri-operative antibiotics	standard	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.
standard peri-operative antibiotics	liver transplant	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.
extended three-day course of antibiotics	extended	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.
extended three-day course of antibiotics	liver transplant	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Development of Surgical Site Infections	within 30 days from surgery	development of surgical site infection, including superficial and deep incisional and organ space surgical site infections

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Post-operative Fever	24 hours from surgery	fever above 38.5 degrees Celsius 24 hours after the end of the liver transplant
Number of Subjects With Elevated White Blood Count (WBC)	24 hours from surgery	above 15,000 within 24hours after the end of the liver transplant
Length of Hospital Stay	within 30 days from surgery	days hospitalized after liver transplant
Number of Subjects With Mortality	within 30 days from surgery	death within 30 days of liver transplant
Number of Subjects With Nosocomial Infection	within 30 days from surgery	diagnosis of any new infection other than an SSI within 30 days from surgery
Number of Subjects With Graft Loss	within 30 days from surgery	complete loss of liver function in recipient