PK/PD of the Sedatives, Analgesics and Antibiotics in Patients Receiving ECMO

Drug Effect Clinical Trial

Official title:

Pharmacokinetics/Pharmacodynamics of the Sedatives, Analgesics and Antibiotics in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03787550
• Other study ID #: ECMO001
• Status: Recruiting
• Start date: February 7, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: May 2019
• Source: Guangdong Provincial People's Hospital
• Contact: Chunbo Chen, Ph. D.
• Phone: +86-20-83827812
• Email: gghccm[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

It is a multi-center, open-label, observational study aimed to understand the pharmacokinetics and pharmacodynamics of the commonly used sedative, analgesic and antibiotic drugs in adult patients supported with extracorporeal membrane oxygenation (ECMO), by measuring the plasma concentrations and the clinical effect of dexmedetomidine, midazolam, butorphanol, remifentanil, sufentanil, propofol, linezolid, tigecycline, teicoplanin, caspofungin, voriconazole and meropenem.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patient given the sedatives, analgesics and antibiotics of interest during ECMO.

• Age from 18 to 85 years old.

• Multiple blood sampling is acceptable.

Exclusion Criteria:

• Patients who are allergic to the investigated drugs.

• Patients who are pregnant.

Related Conditions & MeSH terms

• Drug Effect

Intervention

Drug:
• The Sedatives, analgesics and antibiotics
The sedatives (dexmedetomidine, midazolam, propofol), analgesics (butorphanol, remifentanil, sufentanil), and six antibiotics (linezolid, voriconazole, tigecycline, teicoplanin, caspofungin and meropenem) will be used according to the clinical need.

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Guangzhou First People's Hospital	Guangzhou	Guangdong
China	Nanfang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimum Plasma Concentration [Cmin]	The minimum plasma concentration (the trough concentration), usually collected before the next dose.	Up to 24 hours.
Primary	Area Under the Curve [AUC]	The area under the curve during the dose interval. It also can be calculated by the dose and the clearance of the drug.	Up to 24 hours.
Primary	Maximum Plasma Concentration [Cmax]	The maximum plasma concentration, usually at the end of the infusion during an dose interval.	Up to 24 hours.
Secondary	ICU mortality	The intensive care unit (ICU) mortality is calculated as the number of deaths of the enrolled patients admitted to the ICU, divided by the number of the enrolled patient discharges from the ICU (including deaths and transfers), and often presented as percentage.	Up to 60 days.
Secondary	Hospital mortality	The hospital mortality is calculated as the number of deaths of the enrolled patients divided by the number of the total enrolled patient, and often presented as percentage.	Up to 60 days.
Secondary	Mechanical ventilation duration	Mechanical ventilation duration is the length of days the patients on the mechanical ventilation.	Up to 60 days.
Secondary	ICU length of stay (LOS)	ICU length of stay (LOS) is the length of days the patients in the ICU.	Up to 60 days.