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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


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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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