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|
- dead or alive post treatment [ Time Frame: December 2009 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
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|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177931
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Brian Potoski, PharmD||University of Pittsburgh|