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

Critically Ill Renal Failure Requiring CVVHD and Oseltamivir Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048879
• Other study ID #: HUM00033929
• Status: Completed
• Phase: Phase 4
• First received: January 13, 2010
• Last updated: July 17, 2012
• Start date: October 2009
• Est. completion date: January 2010

Study information

• Verified date: July 2012
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. The purpose of this study is to determine how much oseltamivir gets removed by CVVHD or ECMO in critically ill patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill Renal Failure Requiring CVVHD and Oseltamivir
• Critically Ill Requiring ECMO and Oseltamivir

Intervention

Procedure:
• pharmacokinetic blood sampling
blood samples collected to assess oseltamivir concentrations
• pharmacokinetic blood and dialysate sampling
blood and dialysate samples collected and assayed for oseltamivir concentrations

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Roche Pharma AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous Venovenous Hemodialysis (CVVHD)Oseltamivir Carboxylate Transmembrane Clearance	Oseltamivir Carboxylate Transmembrane Clearance by Continuous Venovenous Hemodialysis (Reported in mL/min).	12 hours	No
Primary	Oseltamivir Carboxylate Removal by ECMO	Mean percent change in oseltamivir carboxylate concentration pre- and post-oxygenator.	12 hours	No