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

• Conditions: Drug Effect
• Interventions: Drug: The Sedatives, analgesics and antibiotics

• Registration Number: NCT03787550
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-12-23
• Study First Posted: 2018-12-26
• Status Verified: 2019-05
• Study Start: 2020-02-07
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-17
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Model building group	The Sedatives, analgesics and antibiotics	The data from the patients in the model building group will be used to build the population PK/PD model. Two to six blood samples will be collected during at least one dose interval at the steady-state, including one sample from the start of ECMO and one at the end of ECMO.
Model validation group	The Sedatives, analgesics and antibiotics	The data from the patients in the model building group will be used to build the population PK/PD model. Two to three blood samples will be collected during at least one dose interval at the steady-state, including one sample from the start of ECMO and one at the end of ECMO.

Primary Outcome Measures

Name	Time	Method
Minimum Plasma Concentration [Cmin]	Up to 24 hours.	The minimum plasma concentration (the trough concentration), usually collected before the next dose.
Maximum Plasma Concentration [Cmax]	Up to 24 hours.	The maximum plasma concentration, usually at the end of the infusion during an dose interval.
Area Under the Curve [AUC]	Up to 24 hours.	The area under the curve during the dose interval. It also can be calculated by the dose and the clearance of the drug.

Secondary Outcome Measures

Name	Time	Method
ICU mortality	Up to 60 days.	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.
Hospital mortality	Up to 60 days.	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.
Mechanical ventilation duration	Up to 60 days.	Mechanical ventilation duration is the length of days the patients on the mechanical ventilation.
ICU length of stay (LOS)	Up to 60 days.	ICU length of stay (LOS) is the length of days the patients in the ICU.

Trial Locations

Locations (3)

Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

Guangzhou First People's Hospital; 🇨🇳 Guangzhou, Guangdong, China