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

NCT01048879 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2012-08-21

Study results available
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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.

Conditions

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

Interventions

PROCEDURE

pharmacokinetic blood sampling

blood samples collected to assess oseltamivir concentrations

PROCEDURE

pharmacokinetic blood and dialysate sampling

blood and dialysate samples collected and assayed for oseltamivir concentrations

Sponsors & Collaborators

Principal Investigators

  • Bruce A Mueller, Pharm.D. · University of Michigan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01048879 on ClinicalTrials.gov