Cefepime Pharmacokinetics in Liver Transplant Recipients in an Intensive Care Unit

NCT00177931 | Completed

• 1 other identifier: IRB # 0403014
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Evidence of Liver Transplantation

Keywords

Liver transplant; cefepime; antibiotics

Outcome Measures

Primary Outcomes (1)

• dead or alive post treatment

  December 2009

Study Arms (1)

liver transplant patients in ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Liver transplant patients in the ICU

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

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 Officials

• Brian Potoski, PharmD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: March 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 17, 2015

Record last verified: 2015-12

Locations

US (1)