Cefepime Pharmacokinetics in Liver Transplant Recipients in an Intensive Care Unit
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 population.
II. Perform stochastic modeling using the population pharmacokinetic parameters obtained in Specific Aim I to determine the ideal dose and dosing regimen of cefepime required to attain predetermined therapeutic targets in liver transplant patients.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Cefepime Pharmacokinetics in Liver Transplant Recipients in an Intensive Care Unit|
All biologic samples will be under the control of the principal investigator of this research project. To protect confidentiality, all personal identifiers will be removed and replaced with a specific code number. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location. The investigators on this study will keep the samples indefinitely. All samples will be provided to investigators not associated with the study without any identifiers and only contain a code number. If a subject withdraws samples collected and not already processed will be destroyed.
|Study Start Date:||March 2005|
|Study Completion Date:||December 2009|
|liver transplant patients in ICU|
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 creatinine as a method of estimating creatinine clearance is not the optimal way to determine the best cefepime dose. The consequence of this non-optimal exposure is the unattainability of therapeutic targets. These therapeutic targets are correlated with positive microbiologic outcome and clinical cure.
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Brian Potoski, PharmD||University of Pittsburgh|