Pharmacokinetics in Extracorporeal Membrane Oxygenation

China-Japan Friendship Hospital

Status: Unknown

Conditions: Extracorporeal Membrane Oxygenation; Pharmacokinetics

Treatments: Device: ECMO

Study type: Observational

Funder types: Other

Identifiers

NCT03766282

2017-2-QN-15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

Animal study

Description:

Critically ill animal on ECMO. PK data from critically ill animal on ECMO will be compared with data from controls and healthy animal on ECMO.

Treatment:

Device: ECMO

Clinical study

Description:

To describe variation of plasma concentration of drugs in patients receiving ECMO, as compared with patients without ECMO.And develop population PK model for ECMO patients.

Treatment:

Device: ECMO