Cefepime Pharmacokinetics in Liver Transplant Recipients... | NCT00177931

Studies
Cefepime Pharmacokinetics in Liver Transplant Recipients in an Intensive Care Unit

NCT00177931

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Dec 17, 2015Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Evidence of Liver Transplantation

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2015

Last Update Posted Date

Dec 17, 2015Estimated

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

25Actual

Label	Type	Description	Intervention Names
liver transplant patients in ICU

Measure	Description	Time Frame
dead or alive post treatment		December 2009

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Liver transplant patients in the ICU

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brian Potoski, PharmD	University of Pittsburgh Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pittsburgh Medical Center		Pittsburgh	Pennsylvania	15213	United States

Description

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.