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Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics

Primary Purpose

Liver Transplantation, Surgical Site Infection

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
standard
extended
liver transplant
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    standard peri-operative antibiotics

    extended three-day course of antibiotics

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Number of Subjects With Development of Surgical Site Infections
    development of surgical site infection, including superficial and deep incisional and organ space surgical site infections

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 2, 2016
    Last Updated
    June 18, 2018
    Sponsor
    University of Virginia
    Collaborators
    National Institute of Allergy and Infectious Diseases (NIAID)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02717273
    Brief Title
    Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics
    Official Title
    A Randomized, Prospective Study of Surgical Site Infections in Liver Transplant Patients Receiving Three Days of Peri-operative Antibiotic Prophylaxis Versus Intra-operative Antibiotics Only
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2009 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Virginia
    Collaborators
    National Institute of Allergy and Infectious Diseases (NIAID)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Transplantation, Surgical Site Infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    102 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    standard peri-operative antibiotics
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    extended three-day course of antibiotics
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    standard
    Other Intervention Name(s)
    Peri-operative only antibiotics
    Intervention Description
    peri-operative antibiotic regimen only
    Intervention Type
    Drug
    Intervention Name(s)
    extended
    Other Intervention Name(s)
    Extended, three-day antibiotics
    Intervention Description
    extended three-day course of antibiotics
    Intervention Type
    Other
    Intervention Name(s)
    liver transplant
    Intervention Description
    orthotopic liver transplantation
    Primary Outcome Measure Information:
    Title
    Number of Subjects With Development of Surgical Site Infections
    Description
    development of surgical site infection, including superficial and deep incisional and organ space surgical site infections
    Time Frame
    within 30 days from surgery
    Secondary Outcome Measure Information:
    Title
    Number of Subjects With Post-operative Fever
    Description
    fever above 38.5 degrees Celsius 24 hours after the end of the liver transplant
    Time Frame
    24 hours from surgery
    Title
    Number of Subjects With Elevated White Blood Count (WBC)
    Description
    above 15,000 within 24hours after the end of the liver transplant
    Time Frame
    24 hours from surgery
    Title
    Number of Subjects With Nosocomial Infection
    Description
    diagnosis of any new infection other than an SSI within 30 days from surgery
    Time Frame
    within 30 days from surgery
    Title
    Length of Hospital Stay
    Description
    days hospitalized after liver transplant
    Time Frame
    within 30 days from surgery
    Title
    Number of Subjects With Graft Loss
    Description
    complete loss of liver function in recipient
    Time Frame
    within 30 days from surgery
    Title
    Number of Subjects With Mortality
    Description
    death within 30 days of liver transplant
    Time Frame
    within 30 days from surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert G Sawyer, MD
    Organizational Affiliation
    UVA
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    32799356
    Citation
    Chan S, Ng S, Chan HP, Pascoe EM, Playford EG, Wong G, Chapman JR, Lim WH, Francis RS, Isbel NM, Campbell SB, Hawley CM, Johnson DW. Perioperative antibiotics for preventing post-surgical site infections in solid organ transplant recipients. Cochrane Database Syst Rev. 2020 Aug 4;8(8):CD013209. doi: 10.1002/14651858.CD013209.pub2.
    Results Reference
    derived

    Learn more about this trial

    Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics

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