Trial Outcomes & Findings for Pharmacokinetics of Tamiflu® (Oseltamivir) in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)and or Continuous Venovenous Hemodialysis (CVVHD) (NCT NCT01048879)

NCT ID: NCT01048879

Last Updated: 2012-08-21

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 15 participants
• Primary outcome timeframe: 12 hours
• Results posted on: 2012-08-21

Participant Flow

Participant milestones

Measure	ECMO Alone Patients receiving oseltamivir and Extracorporeal Membrane Oxygenation (ECMO) therapy	CVVHD Alone Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir	CVVHD + ECMO Patient receiving oseltamivir and ECMO and CVVHD
Overall Study STARTED	1	9	5
Overall Study COMPLETED	1	9	5
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	ECMO Alone n=1 Participants Patients receiving oseltamivir and Extracorporeal Membrane Oxygenation (ECMO) therapy	CVVHD Alone n=9 Participants Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir	CVVHD + ECMO n=5 Participants Patient receiving oseltamivir and ECMO and CVVHD	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	48 years STANDARD_DEVIATION 0 • n=5 Participants	33.0 years STANDARD_DEVIATION 10.2 • n=7 Participants	32.2 years STANDARD_DEVIATION 16.1 • n=5 Participants	33.8 years STANDARD_DEVIATION 12.4 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Region of Enrollment United States	1 participants n=5 Participants	9 participants n=7 Participants	5 participants n=5 Participants	15 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	CVVHD Alone n=8 Participants Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir	CVVHD + ECMO n=5 Participants Patients receiving oseltamivir and ECMO and CVVHD	ECMO Alone Patients receiving ECMO only
Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance	52.2 mL/min Standard Deviation 8.0	43.3 mL/min Standard Deviation 6.7	—

PRIMARY outcome

Timeframe: 12 hours

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

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

Outcome measures

Measure	CVVHD Alone Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir	CVVHD + ECMO n=5 Participants Patients receiving oseltamivir and ECMO and CVVHD	ECMO Alone n=1 Participants Patients receiving ECMO only
Oseltamivir Carboxylate Removal by ECMO	—	-0.008 percent change in concentration Standard Deviation 0.101	-0.033 percent change in concentration Standard Deviation 0.082

Adverse Events

ECMO Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CVVHD Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CVVHD + ECMO

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bruce A. Mueller

University of Michigan

Phone: 7346154578

Email: muellerb@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place