Pharmacokinetics of Ertapenem in Continuous Venovenous Hemodialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bruce A. Mueller, University of Michigan
ClinicalTrials.gov Identifier:
NCT00877370
First received: April 3, 2009
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Acute Kidney Failure
Drug: ertapenem
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pharmacokinetics of Invanz® (Ertapenem) in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Ertapenem Transmembrane Clearance by Continuous Hemodialysis. [ Time Frame: 24 hours after receiving first 1 gram dose ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: February 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Invanz

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877370

Locations
United States, Michigan
University of Michigan University Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Bruce A Mueller, Pharm.D. University of Michigan
  More Information

No publications provided by University of Michigan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bruce A. Mueller, Professor of Pharmacy, University of Michigan
ClinicalTrials.gov Identifier: NCT00877370     History of Changes
Other Study ID Numbers: HUM00022460
Study First Received: April 3, 2009
Results First Received: August 29, 2012
Last Updated: August 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
ertapenem
continuous hemodialysis
pharmacokinetics

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Ertapenem
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014