Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02717273

Enrollment

102

Registered

2016-03-23

Start date

2009-03-31

Completion date

2015-10-31

Last updated

2018-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplantation, Surgical Site Infection

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.

Interventions

DRUGstandard

peri-operative antibiotic regimen only

DRUGextended

extended three-day course of antibiotics

OTHERliver transplant

orthotopic liver transplantation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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 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 Graft Loss	within 30 days from surgery	complete loss of liver function in recipient
Number of Subjects With Mortality	within 30 days from surgery	death within 30 days of liver transplant
Length of Hospital Stay	within 30 days from surgery	days hospitalized after liver transplant

Participant flow

Participants by arm

Arm	Count
Standard Peri-operative Antibiotic Regimen 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 antibiotic regimen only steroids: 500mg methylprednisolone intravenously liver transplant: orthotopic liver transplantation	52
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. extended: extended three-day course of antibiotics steroids: 500mg methylprednisolone intravenously liver transplant: orthotopic liver transplantation	50
Total	102

Baseline characteristics

Characteristic	Extended Three-day Course of Antibiotics	Standard Peri-operative Antibiotic Regimen	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	6 Participants	6 Participants	12 Participants
Age, Categorical Between 18 and 65 years	44 Participants	46 Participants	90 Participants
Age, Continuous	58.5 years	56 years	57.5 years
Region of Enrollment United States	50 Participants	52 Participants	102 Participants
Sex: Female, Male Female	11 Participants	22 Participants	33 Participants
Sex: Female, Male Male	39 Participants	30 Participants	69 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 48	0 / 49
serious Total, serious adverse events	0 / 48	0 / 49

Outcome results

Primary

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

Time frame: within 30 days from surgery