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

Pharmacokinetics of Tamiflu® (Oseltamivir) in Patients Receiving CVVHD and/or ECMO

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01048879
Enrollment
15
Registered
2010-01-14
Start date
2009-10-31
Completion date
2010-01-31
Last updated
2012-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREpharmacokinetic blood sampling

blood samples collected to assess oseltamivir concentrations

PROCEDUREpharmacokinetic blood and dialysate sampling

blood and dialysate samples collected and assayed for oseltamivir concentrations

Sponsors

Roche Pharma AG
CollaboratorINDUSTRY
University of Michigan
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance12 hoursOseltamivir Carboxylate Transmembrane Clearance by Continuous Venovenous Hemodialysis (Reported in mL/min).
Oseltamivir Carboxylate Removal by ECMO12 hoursMean percent change in oseltamivir carboxylate concentration pre- and post-oxygenator.

Countries

United States

Participant flow

Participants by arm

ArmCount
ECMO Alone
Patients receiving oseltamivir and Extracorporeal Membrane Oxygenation (ECMO) therapy
1
CVVHD Alone
Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
9
CVVHD + ECMO
Patient receiving oseltamivir and ECMO and CVVHD
5
Total15

Baseline characteristics

CharacteristicCVVHD AloneCVVHD + ECMOECMO AloneTotal
Age, Categorical
<=18 years
1 Participants1 Participants0 Participants2 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
8 Participants4 Participants1 Participants13 Participants
Age Continuous33.0 years
STANDARD_DEVIATION 10.2
32.2 years
STANDARD_DEVIATION 16.1
48 years
STANDARD_DEVIATION 0
33.8 years
STANDARD_DEVIATION 12.4
Region of Enrollment
United States
9 participants5 participants1 participants15 participants
Sex: Female, Male
Female
3 Participants1 Participants0 Participants4 Participants
Sex: Female, Male
Male
6 Participants4 Participants1 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 10 / 90 / 5
serious
Total, serious adverse events
0 / 10 / 90 / 5

Outcome results

Primary

Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance

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

Time frame: 12 hours

Population: One patient in the CVVHD Alone group was excluded from the analysis because not enough data points were available for pharmacokinetic modeling.

ArmMeasureValue (MEAN)Dispersion
CVVHD AloneContinuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance52.2 mL/minStandard Deviation 8
CVVHD + ECMOContinuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance43.3 mL/minStandard Deviation 6.7
Primary

Oseltamivir Carboxylate Removal by ECMO

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

Time frame: 12 hours

Population: All of the patients that received ECMO were included. Patients receiving CVVHD Alone did not receive ECMO and were not included.

ArmMeasureValue (MEAN)Dispersion
CVVHD + ECMOOseltamivir Carboxylate Removal by ECMO-0.008 percent change in concentrationStandard Deviation 0.101
ECMO AloneOseltamivir Carboxylate Removal by ECMO-0.033 percent change in concentrationStandard Deviation 0.082

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026