Critically Ill Renal Failure Requiring CVVHD and OseltamivirPhase 4NCT01048879

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

A Phase 4 study testing pharmacokinetic blood sampling and pharmacokinetic blood and dialysate sampling in people with Critically Ill Renal Failure Requiring CVVHD and Oseltamivir and Critically Ill Requiring ECMO and Oseltamivir, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Critically Ill Renal Failure Requiring CVVHD and Oseltamivir, Critically Ill Requiring ECMO and Oseltamivir
What is being tested?: pharmacokinetic blood sampling and pharmacokinetic blood and dialysate sampling
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Oct 2009to Jan 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan Hospital
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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

Conditions: Critically Ill Renal Failure Requiring CVVHD and Oseltamivir, Critically Ill Requiring ECMO and Oseltamivir
Being tested: pharmacokinetic blood sampling, pharmacokinetic blood and dialysate sampling
Keywords: oseltamivir, influenza, continuous renal replacement therapy, extracorporeal membrane oxygenation, pharmacokinetics
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pharmacokinetic blood samplingProcedure or surgery
Also called Tamiflu
blood samples collected to assess oseltamivir concentrations
pharmacokinetic blood and dialysate samplingProcedure or surgery
Also called Tamiflu
blood and dialysate samples collected and assayed for oseltamivir concentrations

Study groups in NCT01048879
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: Procedure: pharmacokinetic blood and dialysate sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance
Oseltamivir Carboxylate Transmembrane Clearance by Continuous Venovenous Hemodialysis (Reported in mL/min).
Measured: 12 hours
Oseltamivir Carboxylate Removal by ECMO
Mean percent change in oseltamivir carboxylate concentration pre- and post-oxygenator.
Measured: 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Jan 2010

First posted14 Jan 2010 (estimated)
Study startOct 2009
Primary completionJan 2010
Study completionJan 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Critically Ill Renal Failure Requiring CVVHD and OseltamivirStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01048879
Sponsor's protocol ID: HUM00033929
Status last verified: Jul 2012
First submitted: 13 Jan 2010
Last updated: 21 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 23208833

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics of Tamiflu® (Oseltamivir) in Patients Receiving CVVHD and/or ECMO
ClinicalTrials.gov ID: NCT01048879
Acronym / sponsor ID: HUM00033929
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
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: Roche Pharma AG
Study start: Oct 2009
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 14 Jan 2010 (estimated)
Results: Posted 21 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
ECMO alone	Other	Procedure: pharmacokinetic blood samplingPatients receiving oseltamivir and Extracorporeal Membrane Oxygenation (ECMO) therapy (patients were already receiving oseltamivir and ECMO due to an illness)- Procedure/Surgery: pharmacokinetic blood sampling
CVVHD Alone	Other	Procedure: pharmacokinetic blood and dialysate samplingPatients 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
CVVHD + ECMO	Other	Procedure: pharmacokinetic blood and dialysate samplingPatient 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

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
pharmacokinetic blood samplingAlso: Tamiflublood samples collected to assess oseltamivir concentrations	Procedure or surgery	ECMO alone
pharmacokinetic blood and dialysate samplingAlso: Tamiflublood and dialysate samples collected and assayed for oseltamivir concentrations	Procedure or surgery	CVVHD + ECMO, CVVHD Alone

Primary outcome

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.

Results and safety

Results posted to the registry on 21 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ECMO Alone	1	1
CVVHD Alone	9	9
CVVHD + ECMO	5	5

Primary outcome: Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance

Time frame: 12 hours. Mean (Standard Deviation). Unit: mL/min

Measure	CVVHD Alone n = 8	CVVHD + ECMO n = 5	ECMO Alone n = 0
Value	52.2 (8.0)	43.3 (6.7)	–

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

Primary outcome: Oseltamivir Carboxylate Removal by ECMO

Time frame: 12 hours. Mean (Standard Deviation). Unit: percent change in concentration

Measure	CVVHD Alone n = 0	CVVHD + ECMO n = 5	ECMO Alone n = 1
Value	–	-0.008 (0.101)	-0.033 (0.082)

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

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ECMO Alone	0 of 1 (0%)	0 of 1 (0%)	Not reported
CVVHD Alone	0 of 9 (0%)	0 of 9 (0%)	Not reported
CVVHD + ECMO	0 of 5 (0%)	0 of 5 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23208833Eyler 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bruce A Mueller, Pharm.D. principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance (time frame: 12 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01048879, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2012.