Pharmacokinetics of Ertapenem in Continuous Venovenous Hemodialysis

August 29, 2012 updated by: Bruce A. Mueller, University of Michigan

Pharmacokinetics of Invanz® (Ertapenem) in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ertapenem
subjects will receive ertapenem while receiving CVVHD
Drug: ertapenem
One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained.
Other Names:
  • Invanz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ertapenem Transmembrane Clearance by Continuous Hemodialysis.
Time Frame: 24 hours after receiving first 1 gram dose
24 hours after receiving first 1 gram dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Bruce A Mueller, Pharm.D., University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

April 3, 2009

First Submitted That Met QC Criteria

April 6, 2009

First Posted (Estimate)

April 7, 2009

Study Record Updates

Last Update Posted (Estimate)

September 28, 2012

Last Update Submitted That Met QC Criteria

August 29, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00022460

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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