CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 15 enrolled
Drug / intervention
pharmacokinetic blood sampling +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01048879
NCT01048879Phase 4Completed
CompareCT.gov

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

University of Michigan·interventional·Posted Jan 14, 2010·Updated Aug 21, 2012

In Brief

A Phase 4 clinical trial evaluating pharmacokinetic blood sampling and pharmacokinetic blood and dialysate sampling for Critically Ill Renal Failure Requiring CVVHD and Oseltamivir and Critically Ill Requiring ECMO and Oseltamivir. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritically Ill Renal Failure Requiring CVVHD and Oseltamivir, Critically Ill Requiring ECMO and Oseltamivir
CountriesUnited States
CollaboratorsRoche Pharma AG

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 14, 2010
Enrollment StartOct 1, 2009
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.5 years ago

Interventions

pharmacokinetic blood samplingprocedure

blood samples collected to assess oseltamivir concentrations

pharmacokinetic blood and dialysate samplingprocedure

blood and dialysate samples collected and assayed for oseltamivir concentrations