Pharmacokinetics of Ertapenem in Continuous Venovenous Hemodialysis

Phase 4

Completed

• Conditions: Acute Kidney Failure
• Interventions: Drug: ertapenem

• Registration Number: NCT00877370
• Lead Sponsor: University of Michigan

Brief 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.

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-04-03
• Study First Submitted QC: 2009-04-06
• Study First Posted: 2009-04-07
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-08
• Results First Submitted: 2012-08-29
• Results First Submitted QC: 2012-08-29
• Last Update Submitted: 2012-08-29
• Results First Posted: 2012-09-28
• Last Update Posted: 2012-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ertapenem	ertapenem	subjects will receive ertapenem while receiving CVVHD

Primary Outcome Measures

Name	Time	Method
Ertapenem Transmembrane Clearance by Continuous Hemodialysis.	24 hours after receiving first 1 gram dose

Trial Locations

Locations (1)

University of Michigan University Hospital; 🇺🇸 Ann Arbor, Michigan, United States