Phase 4
N=15
Pharmacokinetics of Tamiflu® (Oseltamivir) in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)and or Continuous Venovenous Hemodialysis (CVVHD)
Critically Ill Renal Failure Requiring CVVHD and Oseltamivir · Critically Ill Requiring ECMO and Oseltamivir
Bottom Line
View on ClinicalTrials.gov: NCT01048879 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance — 52.2; 43.3 mL/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- pharmacokinetic blood sampling (Procedure); pharmacokinetic blood and dialysate sampling (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance |
52.2; 43.3 | — |
| PRIMARY Oseltamivir Carboxylate Removal by ECMO |
-0.008; -0.033 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01048879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.