Pharmacokinetics in Extracorporeal Membrane Oxygenation

Pharmacokinetics Clinical Trial

Official title:

Pharmacokinetics of Antibiotics, Sedative and Analgesic During Extracorporeal Membrane Oxygenation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03766282
• Other study ID #: 2017-2-QN-15
• Status: Recruiting
• Start date: September 1, 2017
• Est. completion date: December 30, 2021

Study information

• Verified date: December 2018
• Source: China-Japan Friendship Hospital
• Contact: Qingyuan Zhan, MD
• Phone: 13683598417
• Email: zhanqy0915[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2021
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation
• Pharmacokinetics

Intervention

Device:
• ECMO
Extracorporeal membrane oxygenation (ECMO) temporarily supports patients with severe cardio-respiratory failure

Locations

Country	Name	City	State
China	China-Japan Friendship hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The median observed peak concentration(Cmax)	Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs	one-dose period
Primary	The median observed through concentration(Cmin)	Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs	one-dose period
Primary	Volume of distribution(Vd)	PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0	one-dose period
Primary	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
Primary	Inter-compartmental clearance (Q)	PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0	one-dose period
Primary	Clearance(CL)	PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0	one-dose period
Secondary	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