NCT01048879

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

August 21, 2012

Completed
Last Updated

August 21, 2012

Status Verified

July 1, 2012

Enrollment Period

3 months

First QC Date

January 13, 2010

Results QC Date

June 13, 2012

Last Update Submit

July 17, 2012

Conditions

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

Keywords

oseltamivirinfluenzacontinuous renal replacement therapyextracorporeal membrane oxygenationpharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance

    Oseltamivir Carboxylate Transmembrane Clearance by Continuous Venovenous Hemodialysis (Reported in mL/min).

    12 hours

  • Oseltamivir Carboxylate Removal by ECMO

    Mean percent change in oseltamivir carboxylate concentration pre- and post-oxygenator.

    12 hours

Study Arms (3)

ECMO alone

OTHER

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

CVVHD Alone

OTHER

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

CVVHD + ECMO

OTHER

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

Interventions

pharmacokinetic blood samplingPROCEDURE

blood samples collected to assess oseltamivir concentrations

Also known as: Tamiflu
ECMO alone
pharmacokinetic blood and dialysate samplingPROCEDURE

blood and dialysate samples collected and assayed for oseltamivir concentrations

Also known as: Tamiflu
CVVHD + ECMOCVVHD Alone

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • receiving Continuous Venovenous Hemodialysis (CVVHD) or Extracorporeal Membrane Oxygenation (ECMO)
  • require oseltamivir treatment
  • informed consent granted

You may not qualify if:

  • pregnant
  • unable to complete 12 hours of CVVHD or ECMO
  • \<6 kg body weight
  • allergy to oseltamivir

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • 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.

    PMID: 23208833DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Oseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title
Bruce A. Mueller
Organization
University of Michigan
muellerb@umich.edu
7346154578

Study Officials

  • Bruce A Mueller, Pharm.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 14, 2010

Study Start

October 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

August 21, 2012

Results First Posted

August 21, 2012

Record last verified: 2012-07

Locations

US(1)