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Trial record 65 of 118 for:    oseltamivir

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

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ClinicalTrials.gov Identifier: NCT01048879
Recruitment Status : Completed
First Posted : January 14, 2010
Results First Posted : August 21, 2012
Last Update Posted : August 21, 2012
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Bruce A. Mueller, 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.

Condition or disease Intervention/treatment Phase
Critically Ill Renal Failure Requiring CVVHD and Oseltamivir Critically Ill Requiring ECMO and Oseltamivir Procedure: pharmacokinetic blood sampling Procedure: pharmacokinetic blood and dialysate sampling Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Tamiflu® (Oseltamivir) in Patients Receiving CVVHD and/or ECMO
Study Start Date : October 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
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
Procedure: pharmacokinetic blood sampling
blood samples collected to assess oseltamivir concentrations
Other Name: Tamiflu

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

Procedure: pharmacokinetic blood and dialysate sampling
blood and dialysate samples collected and assayed for oseltamivir concentrations
Other Name: Tamiflu

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

Procedure: pharmacokinetic blood and dialysate sampling
blood and dialysate samples collected and assayed for oseltamivir concentrations
Other Name: Tamiflu




Primary Outcome Measures :
  1. Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance [ Time Frame: 12 hours ]
    Oseltamivir Carboxylate Transmembrane Clearance by Continuous Venovenous Hemodialysis (Reported in mL/min).

  2. Oseltamivir Carboxylate Removal by ECMO [ Time Frame: 12 hours ]
    Mean percent change in oseltamivir carboxylate concentration pre- and post-oxygenator.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048879


Locations
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United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Roche Pharma AG
Investigators
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Principal Investigator: Bruce A Mueller, Pharm.D. University of Michigan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bruce A. Mueller, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01048879     History of Changes
Other Study ID Numbers: HUM00033929
First Posted: January 14, 2010    Key Record Dates
Results First Posted: August 21, 2012
Last Update Posted: August 21, 2012
Last Verified: July 2012
Keywords provided by Bruce A. Mueller, University of Michigan:
oseltamivir
influenza
continuous renal replacement therapy
extracorporeal membrane oxygenation
pharmacokinetics
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Oseltamivir
Dialysis Solutions
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmaceutical Solutions