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 Oseltamivir; Critically Ill Requiring ECMO and Oseltamivir
• Interventions: Procedure: pharmacokinetic blood sampling; Procedure: pharmacokinetic blood and dialysate sampling

• 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

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Study First Submitted: 2010-01-13
• Study First Submitted QC: 2010-01-13
• Study First Posted: 2010-01-14
• Results First Submitted: 2012-06-13
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-17
• Last Update Submitted: 2012-07-17
• Results First Posted: 2012-08-21
• Last Update Posted: 2012-08-21

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

Arm && Interventions

Group	Intervention	Description
ECMO alone	pharmacokinetic blood sampling	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
CVVHD Alone	pharmacokinetic blood and dialysate sampling	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
CVVHD + ECMO	pharmacokinetic blood and dialysate sampling	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

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.

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States