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

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
pharmacokinetic blood sampling
pharmacokinetic blood and dialysate sampling
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critically Ill Renal Failure Requiring CVVHD and Oseltamivir focused on measuring oseltamivir, influenza, continuous renal replacement therapy, extracorporeal membrane oxygenation, pharmacokinetics

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

ECMO alone

CVVHD Alone

CVVHD + ECMO

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance
Oseltamivir Carboxylate Transmembrane Clearance by Continuous Venovenous Hemodialysis (Reported in mL/min).
Oseltamivir Carboxylate Removal by ECMO
Mean percent change in oseltamivir carboxylate concentration pre- and post-oxygenator.

Secondary Outcome Measures

Full Information

First Posted
January 13, 2010
Last Updated
July 17, 2012
Sponsor
University of Michigan
Collaborators
Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT01048879
Brief Title
Pharmacokinetics of Tamiflu® (Oseltamivir) in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)and or Continuous Venovenous Hemodialysis (CVVHD)
Official Title
Pharmacokinetics of Tamiflu® (Oseltamivir) in Patients Receiving CVVHD and/or ECMO
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Roche Pharma AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill Renal Failure Requiring CVVHD and Oseltamivir, Critically Ill Requiring ECMO and Oseltamivir
Keywords
oseltamivir, influenza, continuous renal replacement therapy, extracorporeal membrane oxygenation, pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ECMO alone
Arm Type
Other
Arm Description
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
Arm Title
CVVHD Alone
Arm Type
Other
Arm Description
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
Arm Title
CVVHD + ECMO
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
pharmacokinetic blood sampling
Other Intervention Name(s)
Tamiflu
Intervention Description
blood samples collected to assess oseltamivir concentrations
Intervention Type
Procedure
Intervention Name(s)
pharmacokinetic blood and dialysate sampling
Other Intervention Name(s)
Tamiflu
Intervention Description
blood and dialysate samples collected and assayed for oseltamivir concentrations
Primary Outcome Measure Information:
Title
Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance
Description
Oseltamivir Carboxylate Transmembrane Clearance by Continuous Venovenous Hemodialysis (Reported in mL/min).
Time Frame
12 hours
Title
Oseltamivir Carboxylate Removal by ECMO
Description
Mean percent change in oseltamivir carboxylate concentration pre- and post-oxygenator.
Time Frame
12 hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce A Mueller, Pharm.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23208833
Citation
Eyler RF, Heung M, Pleva M, Sowinski KM, Park PK, Napolitano LM, Mueller BA. Pharmacokinetics of oseltamivir and oseltamivir carboxylate in critically ill patients receiving continuous venovenous hemodialysis and/or extracorporeal membrane oxygenation. Pharmacotherapy. 2012 Dec;32(12):1061-9. doi: 10.1002/phar.1151.
Results Reference
derived

Learn more about this trial

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

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