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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

Tracking Information
First Submitted Date  ICMJE January 13, 2010
First Posted Date  ICMJE January 14, 2010
Results First Submitted Date  ICMJE June 13, 2012
Results First Posted Date  ICMJE August 21, 2012
Last Update Posted Date August 21, 2012
Study Start Date  ICMJE October 2009
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2012)
  • Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance [ Time Frame: 12 hours ]
    Oseltamivir Carboxylate Transmembrane Clearance by Continuous Venovenous Hemodialysis (Reported in mL/min).
  • Oseltamivir Carboxylate Removal by ECMO [ Time Frame: 12 hours ]
    Mean percent change in oseltamivir carboxylate concentration pre- and post-oxygenator.
Original Primary Outcome Measures  ICMJE
 (submitted: January 13, 2010)
ECMO/CRRT oseltamivir clearance [ Time Frame: 1 year ]
Change History Complete list of historical versions of study NCT01048879 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of Tamiflu® (Oseltamivir) in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)and or Continuous Venovenous Hemodialysis (CVVHD)
Official Title  ICMJE Pharmacokinetics of Tamiflu® (Oseltamivir) in Patients Receiving CVVHD and/or ECMO
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Critically Ill Renal Failure Requiring CVVHD and Oseltamivir
  • Critically Ill Requiring ECMO and Oseltamivir
Intervention  ICMJE
  • Procedure: pharmacokinetic blood sampling
    blood samples collected to assess oseltamivir concentrations
    Other Name: Tamiflu
  • Procedure: pharmacokinetic blood and dialysate sampling
    blood and dialysate samples collected and assayed for oseltamivir concentrations
    Other Name: Tamiflu
Study Arms  ICMJE
  • 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
    Intervention: Procedure: pharmacokinetic blood sampling
  • 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

    Intervention: Procedure: pharmacokinetic blood and dialysate sampling
  • 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

    Intervention: Procedure: pharmacokinetic blood and dialysate sampling
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2012)
15
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2010)
30
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01048879
Other Study ID Numbers  ICMJE HUM00033929
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bruce A. Mueller, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Roche Pharma AG
Investigators  ICMJE
Principal Investigator: Bruce A Mueller, Pharm.D. University of Michigan
PRS Account University of Michigan
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP