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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04701099

Enrollment

Registered

2021-01-08

Start date

2020-06-07

Completion date

2023-04-30

Last updated

2021-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Patients Receiving Venoarterial Extracorporeal Membrane Oxygenation

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to 18 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Serum or plasma concentration	Between day0 to day3 during ECMO	Serum or plasma concentration of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
Pharmacokinetic parameter: Volume of distribution	Between day0 to day3 during ECMO	Volume of distribution of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
Pharmacokinetic parameter: Clearance	Between day0 to day3 during ECMO	Clearance of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl

Countries

South Korea

Contacts

Primary ContactYu Rim Shin, Assistant Professor

yull0629@yuhs.ac82-2-2228-8480

Outcome results