Pharmacokinetics of Ertapenem in Continuous Venovenous Hemodialysis

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University of Michigan

Status and phase

Completed
Phase 4

Conditions

Acute Kidney Failure

Treatments

Drug: ertapenem

Study type

Interventional

Funder types

Other

Identifiers

NCT00877370
HUM00022460

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

8 participants in 1 patient group

ertapenem
Experimental group
Description:
subjects will receive ertapenem while receiving CVVHD
Treatment:
Drug: ertapenem

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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