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Pharmacokinetics in Extracorporeal Membrane Oxygenation
Beijing, China
N/A
Waitlist Available
Research Sponsored by China-Japan Friendship Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one-dose period
Awards & highlights
No Placebo-Only Group
Summary
The main purpose of the present study is to investigate the risk factors that affect drug pharmacokinetic (PK) during extracorporeal membrane oxygenation (ECMO). To advance understanding of PK variance and improve the patients outcomes during ECMO.
See full description
Eligible Conditions
- Extracorporeal Membrane Oxygenation
- Pharmacokinetics
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one-dose period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one-dose period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Area under the plasma concentration versus time curve (AUC)
Clearance(CL)
Inter-compartmental clearance (Q)
+3 moreSecondary study objectives
Development of strategies for drug administration in critically ill patients receiving ECMO
Side effects data
From 2013 Phase 1 & 2 trial • 6 Patients • NCT0166986317%
Accidental ECMO line removal
100%
80%
60%
40%
20%
0%
Study treatment Arm
Use of ECMO in Non-intubated Patients
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Clinical studyExperimental Treatment1 Intervention
To describe variation of plasma concentration of drugs in patients receiving ECMO, as compared with patients without ECMO.And develop population PK model for ECMO patients.
Group II: Animal studyExperimental Treatment1 Intervention
Critically ill animal on ECMO. PK data from critically ill animal on ECMO will be compared with data from controls and healthy animal on ECMO.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ECMO
2018
Completed Phase 2
~980
Find a Location
Who is running the clinical trial?
China-Japan Friendship HospitalLead Sponsor
245 Previous Clinical Trials
13,660,934 Total Patients Enrolled
Chen WangStudy ChairChina-Japan Friendship Hospital
5 Previous Clinical Trials
12,648 Total Patients Enrolled