Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| T32AI078875 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard peri-operative antibiotics | Active Comparator | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard | Drug | peri-operative antibiotic regimen only |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | within 30 days from surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Post-operative Fever | fever above 38.5 degrees Celsius 24 hours after the end of the liver transplant | 24 hours from surgery |
| Number of Subjects With Elevated White Blood Count (WBC) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert G Sawyer, MD | UVA | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32799356 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Had liver transplant | Posted | Count of Participants | Participants | within 30 days from surgery |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Sawyer | University of Virginia | 4349821632 | rws2k@virginia.edu |
Not provided
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| D016031 | Liver Transplantation |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| extended | Drug | extended three-day course of antibiotics |
|
|
| liver transplant | Other | orthotopic liver transplantation |
|
above 15,000 within 24hours after the end of the liver transplant
| 24 hours from surgery |
| Number of Subjects With Nosocomial Infection | diagnosis of any new infection other than an SSI within 30 days from surgery | within 30 days from surgery |
| Length of Hospital Stay | days hospitalized after liver transplant | within 30 days from surgery |
| Number of Subjects With Graft Loss | complete loss of liver function in recipient | within 30 days from surgery |
| Number of Subjects With Mortality | death within 30 days of liver transplant | within 30 days from surgery |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| 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 |
|
|
| Secondary | Number of Subjects With Post-operative Fever | fever above 38.5 degrees Celsius 24 hours after the end of the liver transplant | Had liver transplant | Posted | Count of Participants | Participants | 24 hours from surgery |
|
|
|
| Secondary | Number of Subjects With Elevated White Blood Count (WBC) | above 15,000 within 24hours after the end of the liver transplant | Had liver transplant | Posted | Count of Participants | Participants | 24 hours from surgery |
|
|
|
| Secondary | Number of Subjects With Nosocomial Infection | diagnosis of any new infection other than an SSI within 30 days from surgery | Had liver transplant | Posted | Count of Participants | Participants | within 30 days from surgery |
|
|
|
| Secondary | Length of Hospital Stay | days hospitalized after liver transplant | Had liver transplant | Posted | Median | Inter-Quartile Range | days | within 30 days from surgery |
|
|
|
| Secondary | Number of Subjects With Graft Loss | complete loss of liver function in recipient | Had liver transplant | Posted | Count of Participants | Participants | within 30 days from surgery |
|
|
|
| Secondary | Number of Subjects With Mortality | death within 30 days of liver transplant | Had liver transplant | Posted | Count of Participants | Participants | within 30 days from surgery |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | 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 | 0 | 49 | 0 | 49 |
Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D016378 |
| Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |