Pharmacokinetics of Antibiotics, Sedative and Analgesic During Extracorporeal Membrane Oxygenation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Extracorporeal Membrane Oxygenation
- Sponsor
- China-Japan Friendship Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- The median observed through concentration(Cmin)
- Last Updated
- 7 years ago
Overview
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.
Investigators
Qingyuan Zhan
Prof.
China-Japan Friendship Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
The median observed through concentration(Cmin)
Time Frame: one-dose period
Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs
The median observed peak concentration(Cmax)
Time Frame: one-dose period
Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs
Volume of distribution(Vd)
Time Frame: one-dose period
PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0
Clearance(CL)
Time Frame: 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)
Time Frame: one-dose period
PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0
Inter-compartmental clearance (Q)
Time Frame: one-dose period
PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0
Secondary Outcomes
- Development of strategies for drug administration in critically ill patients receiving ECMO(one-dose period)