Status:
COMPLETED
Cefepime Pharmacokinetics in Liver Transplant Recipients in an Intensive Care Unit
Lead Sponsor:
University of Pittsburgh
Conditions:
Evidence of Liver Transplantation
Eligibility:
All Genders
18+ years
Brief Summary
The purposes of this study are to: I. Characterize the plasma concentration-time profile of cefepime in liver transplant patients to determine the pharmacokinetic parameters in this patient populatio...
Detailed Description
The use of cefepime in liver transplant patients at conventional doses used for other patient populations leads to non-optimal drug exposure among liver transplant patients. Furthermore, using serum c...
Eligibility Criteria
Inclusion
- Women and members of minority groups will be included in this study. However, as this study seeks to generate pilot data, there will be no specific statistical analysis comparing differences based on gender or race.
- Subjects receiving drugs known to induce or inhibit hepatic enzymes are not excluded from this study as cefepime is renally eliminated and not significantly metabolized by the liver.
- All liver transplant subjects are eligible for enrollment in this study, including subjects who have undergone a living related liver transplant.
- The pharmacokinetics of cefepime in children are significantly different from those of adults. For the purposes of this study only adults (aged \> 18 years old) will be able to participate.
Exclusion
- Subjects will be excluded if they are anemic (hemoglobin \< 7 mg/dl), or are patients with severe gastrointestinal bleeding who are receiving packed red blood cells.
- Subjects who are receiving hemodialysis or other forms of renal replacement therapy (such as continuous veno-venous hemofiltration), or patients with a calculated creatinine clearance of \< 10 ml/min will be excluded from the study.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00177931
Start Date
March 1 2005
End Date
December 1 2009
Last Update
December 17 2015
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213