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

Sponsor

Guangdong Provincial People's Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03787550

Collaborator

(none)

Enrollment

Locations

25.7

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Drug Effect	Drug: The Sedatives, analgesics and antibiotics

Study Design

Study Type:

Observational

Anticipated Enrollment :

36 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Feb 7, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Model building group 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.	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.
Model validation group 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.	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.

Arm

Intervention/Treatment

Model building group

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.

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.

Model validation group

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.

Drug: The Sedatives, analgesics and antibiotics

Outcome Measures

Primary Outcome Measures

Minimum Plasma Concentration [Cmin] [Up to 24 hours.]
The minimum plasma concentration (the trough concentration), usually collected before the next dose.
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.
Maximum Plasma Concentration [Cmax] [Up to 24 hours.]
The maximum plasma concentration, usually at the end of the infusion during an dose interval.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangdong Provincial People's Hospital	Guangzhou	Guangdong	China	510080
2	Guangzhou First People's Hospital	Guangzhou	Guangdong	China
3	Nanfang Hospital	Guangzhou	Guangdong	China