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Pharmacokinetics of Tamiflu® (Oseltamivir) in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)and or Continuous Venovenous Hemodialysis (CVVHD)

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University of Michigan

Status and phase

Completed
Phase 4

Conditions

Critically Ill Renal Failure Requiring CVVHD and Oseltamivir
Critically Ill Requiring ECMO and Oseltamivir

Treatments

Procedure: pharmacokinetic blood and dialysate sampling
Procedure: pharmacokinetic blood sampling

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01048879
HUM00033929

Details and patient eligibility

About

Critically ill patients with flu may receive a drug called oseltamivir. They may also receive medical therapies to support their lung function (extracorporeal membrane oxygenation; ECMO) and kidney function (continuous venovenous hemodialysis; CVVHD). CVVHD and ECMO may remove some oseltamivir from the bloodstream. The purpose of this study is to determine how much oseltamivir gets removed by CVVHD or ECMO in critically ill patients.

Enrollment

15 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • receiving Continuous Venovenous Hemodialysis (CVVHD) or Extracorporeal Membrane Oxygenation (ECMO)
  • require oseltamivir treatment
  • informed consent granted

Exclusion criteria

  • pregnant
  • unable to complete 12 hours of CVVHD or ECMO
  • <6 kg body weight
  • allergy to oseltamivir

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

15 participants in 3 patient groups

ECMO alone
Other group
Description:
Patients receiving oseltamivir and Extracorporeal Membrane Oxygenation (ECMO) therapy (patients were already receiving oseltamivir and ECMO due to an illness)- Procedure/Surgery: pharmacokinetic blood sampling
Treatment:
Procedure: pharmacokinetic blood sampling
CVVHD Alone
Other group
Description:
Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir (Patients were already receiving oseltamivir and CVVHD as a result of an illness). Procedure/Surgery: pharmacokinetic blood and dialysate sampling
Treatment:
Procedure: pharmacokinetic blood and dialysate sampling
CVVHD + ECMO
Other group
Description:
Patient receiving oseltamivir and ECMO and CVVHD (patients were already receiving oseltamivir, ECMO, and CVVHD as part of an illness). Procedure/Surgery: pharmacokinetic blood and dialysate sampling
Treatment:
Procedure: pharmacokinetic blood and dialysate sampling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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