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Cefepime Pharmacokinetics in Liver Transplant Recipients in an Intensive Care Unit

NCT ID: NCT00177931

Last Updated: 2015-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Evidence of Liver Transplantation

Keywords

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Liver transplant cefepime antibiotics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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liver transplant patients in ICU

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian Potoski, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Locations

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University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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IRB # 0403014

Identifier Type: -

Identifier Source: org_study_id