Pharmacokinetics of Tamiflu® (Oseltamivir) in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)and or Continuous Venovenous Hemodialysis (CVVHD)
Phase 4
Completed
- Conditions
- Critically Ill Renal Failure Requiring CVVHD and OseltamivirCritically Ill Requiring ECMO and Oseltamivir
- Registration Number
- NCT01048879
- Lead Sponsor
- University of Michigan
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance 12 hours Oseltamivir Carboxylate Transmembrane Clearance by Continuous Venovenous Hemodialysis (Reported in mL/min).
Oseltamivir Carboxylate Removal by ECMO 12 hours Mean percent change in oseltamivir carboxylate concentration pre- and post-oxygenator.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Michigan Hospital
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Hospital🇺🇸Ann Arbor, Michigan, United States