Population Pharmacokinetics of Vancomycin, Meropenem, Milrinone, Dexmedetomidine and Fentanyl in Pediatric Patients During Extracorporeal Membrane Oxygenation

Yonsei University

Status: Unknown

Conditions: Pediatric Patients Receiving Venoarterial Extracorporeal Membrane Oxygenation

Study type: Observational

Funder types: Other

Identifiers

NCT04701099

4-2020-0182

Details and patient eligibility

About

Extracorporeal membrane oxygenation (ECMO) has been used primarily in newborns since it was first successfully implemented in the 1970s, and has recently increased use in infants and young children. Venoarterial ECMO (VA-ECMO) is a temporary mechanical circulatory support for patients with cardiac failure. Because ECMO is invasive, appropriate use of antimicrobial agent, analgesic and sedatives is important to promote recovery. However, a large variability in drugs pharmacokinetics is expected in pediatric ECMO patients due to the combination of ECMO, drug characteristics and disease factor. This study aimed to evaluate whether the PK of drugs is influenced by VA-ECMO and to recommend the optimal dosing strategies for proposed drugs in pediatric patients receiving VA-ECMO.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• <19 years old
• receiving VA ECMO in Severance Hospital, Yonsei University Health System.
• receiving one of these drugs: vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
• agreed to participate

Exclusion criteria

• receiving drugs that could affect study drug's concentration due to drug-drug interaction

Trial design

50 participants in 2 patient groups

On ECMO

Description:

patients who is receiving vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl during ECMO support.

Off ECMO

Description:

patients who is receiving vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl after weaning off ECMO.