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OpenTrials
Completed

NCT Number: NCT01048879

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

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.

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Key information

Conditions

Critically Ill Renal Failure Requiring CVVHD and Oseltamivir Critically Ill Requiring ECMO and Oseltamivir Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pharmacokinetic blood sampling

Procedure

blood samples collected to assess oseltamivir concentrations

Other names: Tamiflu

pharmacokinetic blood and dialysate sampling

Procedure

blood and dialysate samples collected and assayed for oseltamivir concentrations

Other names: Tamiflu

Primary outcomes

  1. Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance

    Time frame: 12 hours

    Oseltamivir Carboxylate Transmembrane Clearance by Continuous Venovenous Hemodialysis (Reported in mL/min).

  2. Oseltamivir Carboxylate Removal by ECMO

    Time frame: 12 hours

    Mean percent change in oseltamivir carboxylate concentration pre- and post-oxygenator.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study title

Pharmacokinetics of Tamiflu® (Oseltamivir) in Patients Receiving CVVHD and/or ECMO

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 14, 2010
Registry last updated
Aug 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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