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Sponsored by: |
University of Pittsburgh |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00177931 |
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.
Condition |
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Liver Transplantation |
Study Type: | Observational |
Study Design: | Cohort, 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.
Estimated Enrollment: | 25 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | December 2009 |
Groups/Cohorts |
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Liver transplant patients in the ICU
Inclusion Criteria:
Exclusion Criteria:
Contact: Brian Potoski, PharmD | 412-648-6401 | potoba@upmc.edu |
Contact: Diana Pakstis, RN, BSN | 412-648-6401 | pakstisdl@dom.pitt.edu |
United States, Pennsylvania | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Brian Potoski, PharmD 412-648-6401 potoba@upmc.edu | |
Contact: Diana Pakstis, RN, BSN 412-648-6401 paksdl@dom.pitt.edu | |
Principal Investigator: Brian Potoski, PharmD |
Principal Investigator: | Brian Potoski, PharmD | University of Pittsburgh |
Responsible Party: | UPMC ( Brian Potoski, Pharm D ) |
Study ID Numbers: | IRB # 0403014 |
Study First Received: | September 13, 2005 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00177931 History of Changes |
Health Authority: | United States: Institutional Review Board |
Liver transplant cefepime antibiotics |
Anti-Bacterial Agents Cefepime |
Anti-Infective Agents Anti-Bacterial Agents Cefepime Therapeutic Uses Pharmacologic Actions |