Pharmacokinetics of Ertapenem in Continuous Venovenous Hemodialysis
Information source: University of Michigan
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Kidney Failure
Intervention: ertapenem (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Michigan Official(s) and/or principal investigator(s): Bruce A Mueller, Pharm.D., Principal Investigator, Affiliation: University of Michigan
Summary
Critically ill patients in the intensive care unit often receive continuous hemodialysis to
treat their kidney failure. Ertapenem is an antibiotic often used in these patients.
Continuous dialysis may remove ertapenem, putting patients at risk for inappropriate
treatment of their infection. This study will determine how much ertapenem is removed by
continuous hemodialysis.
Clinical Details
Official title: Pharmacokinetics of Invanz® (Ertapenem) in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Ertapenem Transmembrane Clearance by Continuous Hemodialysis.
Detailed description:
Subjects receiving CVVHD will receive a one gram dose of ertapenem. Serial blood samples
over 24 hours will be taken to assess the ertapenem blood concentrations over time. Spent
dialysate and urine samples (if any) will also be measured for ertapenem content to
determine how much drug is removed by CVVHD and kidneys. A pharmacokinetic evaluation will
be made to determine what is the most appropriate dose for this drug in patients receiving
CVVHD to achieve pharmacokinetic and pharmacodynamic goals.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Hospitalized in ICU
- Receiving Continuous hemodialysis
- Prescribed ertapenem
- Informed consent granted
Exclusion Criteria:
- < 18 years of age
- Allergy to ertapenem or other carbapenem antibiotic
- Severe, life-threatening reaction to penicillin or cephalosporins
- Patients experiencing or with history of CNS disorders (eg: seizure, stroke)
- Patients experiencing CNS infection
- Inability to complete 24 hours of CVVHD
- Concurrent use of other extracorporeal therapies such as extracorporeal membrane
oxygenation, plasmapheresis or intermittent hemodialysis
- Inability to obtain informed consent
- Pregnant and/or breastfeeding women
Locations and Contacts
University of Michigan University Hospital, Ann Arbor, Michigan 48109, United States
Additional Information
Starting date: February 2009
Last updated: August 29, 2012
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