Cefepime Pharmacokinetics in Liver Transplant Recipients in an Intensive Care Unit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00177931
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : December 17, 2015
Information provided by (Responsible Party):
University of Pittsburgh

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 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 or disease
Evidence of Liver Transplantation

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 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.

Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cefepime Pharmacokinetics in Liver Transplant Recipients in an Intensive Care Unit
Study Start Date : March 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

liver transplant patients in ICU

Primary Outcome Measures :
  1. dead or alive post treatment [ Time Frame: December 2009 ]

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Liver transplant patients in the ICU

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00177931

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: Brian Potoski, PharmD University of Pittsburgh

Responsible Party: University of Pittsburgh Identifier: NCT00177931     History of Changes
Other Study ID Numbers: IRB # 0403014
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: December 2015

Keywords provided by University of Pittsburgh:
Liver transplant

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents