Extracorporeal Membrane Oxygenation, Pharmacokinetics
Conditions
Keywords
Pharmacokinetics, extracorporeal membrane oxygenation
Brief 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.
Detailed description
Ex vivo experiments for drug stability testing and ECMO circuits testing in animal models.PK studies in healthy animals and critically ill animal models with or without ECMO to define the PK alterations. Clinical PK studies in critically ill patients on ECMO.
Interventions
DEVICEECMO
Extracorporeal membrane oxygenation (ECMO) temporarily supports patients with severe cardio-respiratory failure
Sponsors
China-Japan Friendship Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are undergoing ECMO for respiratory and or cardiac dysfunction * Clinical indication for the antibiotics * Clinical indication for the sedatives and analgesics
Exclusion criteria
* No consent * Known allergy to study drug * Pregnancy * Massive fluid resuscitation (\>50% blood volume transfused) in the previous 8 hours. * Therapeutic plasma exchange in the preceding 24 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of distribution(Vd) | one-dose period | PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0 |
| The median observed peak concentration(Cmax) | one-dose period | Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs |
| The median observed through concentration(Cmin) | one-dose period | Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs |
| Clearance(CL) | one-dose period | PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0 |
| Area under the plasma concentration versus time curve (AUC) | one-dose period | PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0 |
| Inter-compartmental clearance (Q) | one-dose period | PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Development of strategies for drug administration in critically ill patients receiving ECMO | one-dose period | PK models for study drugs using a non-linear mixed effects modeling approach. |
Countries
China
Contacts
Primary ContactQingyuan Zhan, MD
Backup ContactMin Li, MD
Outcome results
None listed