Pharmacokinetics in Extracorporeal Membrane Oxygenation

• Conditions: Pharmacokinetics; Extracorporeal Membrane Oxygenation
• Interventions: Device: ECMO

• Registration Number: NCT03766282
• Lead Sponsor: China-Japan Friendship Hospital

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.

Study Timeline

• Study Start: 2017-09-01
• Status Verified: 2018-12
• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-05
• Last Update Submitted: 2018-12-05
• Study First Posted: 2018-12-06
• Last Update Posted: 2018-12-06
• Primary Completion: 2020-07-01
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Animal study	ECMO	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.
Clinical study	ECMO	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.

Primary Outcome Measures

Name	Time	Method
The median observed through concentration(Cmin)	one-dose period	Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs
The median observed peak concentration(Cmax)	one-dose period	Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs
Volume of distribution(Vd)	one-dose period	PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

China-Japan Friendship hospital; 🇨🇳 Beijing, Beijing, China