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

NCT ID: NCT01048879

Last Updated: 2012-08-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-01-31

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.

Detailed Description

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Conditions

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

Keywords

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oseltamivir influenza continuous renal replacement therapy extracorporeal membrane oxygenation pharmacokinetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ECMO alone

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

Group Type OTHER

pharmacokinetic blood sampling

Intervention Type PROCEDURE

blood samples collected to assess oseltamivir concentrations

CVVHD Alone

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

Group Type OTHER

pharmacokinetic blood and dialysate sampling

Intervention Type PROCEDURE

blood and dialysate samples collected and assayed for oseltamivir concentrations

CVVHD + ECMO

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

Group Type OTHER

pharmacokinetic blood and dialysate sampling

Intervention Type PROCEDURE

blood and dialysate samples collected and assayed for oseltamivir concentrations

Interventions

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pharmacokinetic blood sampling

blood samples collected to assess oseltamivir concentrations

Intervention Type PROCEDURE

pharmacokinetic blood and dialysate sampling

blood and dialysate samples collected and assayed for oseltamivir concentrations

Intervention Type PROCEDURE

Other Intervention Names

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Tamiflu Tamiflu

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Bruce A. Mueller

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruce A Mueller, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan Hospital

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23208833 (View on PubMed)

Other Identifiers

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HUM00033929

Identifier Type: -

Identifier Source: org_study_id