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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Procedure: pharmacokinetic blood sampling
* Procedure: pharmacokinetic blood and dialysate sampling


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ECMO alone<br>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 | Procedure: pharmacokinetic blood sampling<br>* blood samples collected to assess oseltamivir concentrations<br>* Other names: Tamiflu;|
| Other: CVVHD Alone<br>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 | Procedure: pharmacokinetic blood and dialysate sampling<br>* blood and dialysate samples collected and assayed for oseltamivir concentrations<br>* Other names: Tamiflu;|
| Other: CVVHD + ECMO<br>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 | Procedure: pharmacokinetic blood and dialysate sampling<br>* blood and dialysate samples collected and assayed for oseltamivir concentrations<br>* Other names: Tamiflu;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance | Oseltamivir Carboxylate Transmembrane Clearance by Continuous Venovenous Hemodialysis (Reported in mL/min). | 12 hours | 
| Oseltamivir Carboxylate Removal by ECMO | Mean percent change in oseltamivir carboxylate concentration pre- and post-oxygenator. | 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oseltamivir, influenza, continuous renal replacement therapy, extracorporeal membrane oxygenation, pharmacokinetics