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

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Unknown

Conditions: Drug Effect

Treatments: Drug: The Sedatives, analgesics and antibiotics

Study type: Observational

Funder types: Other

Identifiers

NCT03787550

ECMO001

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

36 participants in 2 patient groups

Model building group

Description:

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.

Treatment:

Drug: The Sedatives, analgesics and antibiotics

Model validation group

Description:

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.

Treatment:

Drug: The Sedatives, analgesics and antibiotics