Pharmacokinetics in Extracorporeal Membrane Oxygenation

Pharmacokinetics of Antibiotics, Sedative and Analgesic During Extracorporeal Membrane Oxygenation

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.

Study Overview

• Status: Unknown
• Conditions: Extracorporeal Membrane Oxygenation; Pharmacokinetics
• Intervention / Treatment: Device: 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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Qingyuan Zhan, MD; Phone Number: 13683598417; Email: zhanqy0915@163.com
• Study Contact Backup: Name: Min Li, MD; Phone Number: 13683598417; Email: qlyy_limin@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100028
      • Recruiting
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are undergoing ECMO

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Animal study; 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.	Device: ECMO; Extracorporeal membrane oxygenation (ECMO) temporarily supports patients with severe cardio-respiratory failure; Other Names: Extracorporeal membrane oxygenation
Clinical study; 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.	Device: ECMO; Extracorporeal membrane oxygenation (ECMO) temporarily supports patients with severe cardio-respiratory failure; Other Names: Extracorporeal membrane oxygenation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The median observed peak concentration(Cmax)	Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs	one-dose period
The median observed through concentration(Cmin)	Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs	one-dose period
Volume of distribution(Vd)	PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0	one-dose period
Area under the plasma concentration versus time curve (AUC)	PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0	one-dose period
Inter-compartmental clearance (Q)	PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0	one-dose period
Clearance(CL)	PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0	one-dose period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of strategies for drug administration in critically ill patients receiving ECMO	PK models for study drugs using a non-linear mixed effects modeling approach.	one-dose period

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Investigators: Study Chair: Chen Wang, China-Japan Friendship Hospital

Publications and helpful links

General Publications

• Wang Q, Zhang Z, Liu D, Chen W, Cui G, Li P, Zhang X, Li M, Zhan Q, Wang C. Population Pharmacokinetics of Caspofungin among Extracorporeal Membrane Oxygenation Patients during the Postoperative Period of Lung Transplantation. Antimicrob Agents Chemother. 2020 Oct 20;64(11):e00687-20. doi: 10.1128/AAC.00687-20. Print 2020 Oct 20.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): December 6, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Pharmacokinetics; extracorporeal membrane oxygenation
• Other Study ID Numbers: 2017-2-QN-15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No