Trial Outcomes & Findings for Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics (NCT NCT02717273)
NCT ID: NCT02717273
Last Updated: 2018-07-17
Results Overview
development of surgical site infection, including superficial and deep incisional and organ space surgical site infections
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
102 participants
Primary outcome timeframe
within 30 days from surgery
Results posted on
2018-07-17
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
50
|
|
Overall Study
COMPLETED
|
49
|
48
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics
Baseline characteristics by cohort
| Measure |
Standard Peri-operative Antibiotic Regimen
n=52 Participants
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
|
Extended Three-day Course of Antibiotics
n=50 Participants
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
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
56 years
n=5 Participants
|
58.5 years
n=7 Participants
|
57.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 30 days from surgeryPopulation: Had liver transplant
development of surgical site infection, including superficial and deep incisional and organ space surgical site infections
Outcome measures
| Measure |
Standard Peri-operative Antibiotic Regimen
n=48 Participants
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
|
Extended Three-day Course of Antibiotics
n=49 Participants
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
|
|---|---|---|
|
Number of Subjects With Development of Surgical Site Infections
|
9 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 24 hours from surgeryPopulation: Had liver transplant
fever above 38.5 degrees Celsius 24 hours after the end of the liver transplant
Outcome measures
| Measure |
Standard Peri-operative Antibiotic Regimen
n=48 Participants
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
|
Extended Three-day Course of Antibiotics
n=49 Participants
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
|
|---|---|---|
|
Number of Subjects With Post-operative Fever
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 24 hours from surgeryPopulation: Had liver transplant
above 15,000 within 24hours after the end of the liver transplant
Outcome measures
| Measure |
Standard Peri-operative Antibiotic Regimen
n=48 Participants
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
|
Extended Three-day Course of Antibiotics
n=49 Participants
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
|
|---|---|---|
|
Number of Subjects With Elevated White Blood Count (WBC)
|
42 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: within 30 days from surgeryPopulation: Had liver transplant
diagnosis of any new infection other than an SSI within 30 days from surgery
Outcome measures
| Measure |
Standard Peri-operative Antibiotic Regimen
n=48 Participants
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
|
Extended Three-day Course of Antibiotics
n=49 Participants
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
|
|---|---|---|
|
Number of Subjects With Nosocomial Infection
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: within 30 days from surgeryPopulation: Had liver transplant
days hospitalized after liver transplant
Outcome measures
| Measure |
Standard Peri-operative Antibiotic Regimen
n=48 Participants
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
|
Extended Three-day Course of Antibiotics
n=49 Participants
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
|
|---|---|---|
|
Length of Hospital Stay
|
7.5 days
Interval 6.5 to 11.0
|
7.5 days
Interval 6.0 to 12.0
|
SECONDARY outcome
Timeframe: within 30 days from surgeryPopulation: Had liver transplant
complete loss of liver function in recipient
Outcome measures
| Measure |
Standard Peri-operative Antibiotic Regimen
n=48 Participants
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
|
Extended Three-day Course of Antibiotics
n=49 Participants
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
|
|---|---|---|
|
Number of Subjects With Graft Loss
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: within 30 days from surgeryPopulation: Had liver transplant
death within 30 days of liver transplant
Outcome measures
| Measure |
Standard Peri-operative Antibiotic Regimen
n=48 Participants
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
|
Extended Three-day Course of Antibiotics
n=49 Participants
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
|
|---|---|---|
|
Number of Subjects With Mortality
|
1 Participants
|
1 Participants
|
Adverse Events
Standard Peri-operative Antibiotic Regimen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Extended Three-day Course of Antibiotics
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place