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

• Conditions: Pediatric Patients Receiving Venoarterial Extracorporeal Membrane Oxygenation

• Registration Number: NCT04701099
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-07
• Status Verified: 2021-01
• Study First Submitted: 2021-01-03
• Study First Submitted QC: 2021-01-05
• Last Update Submitted: 2021-01-05
• Study First Posted: 2021-01-08
• Last Update Posted: 2021-01-08
• Primary Completion: 2023-04
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameter: Clearance	Between day0 to day3 after weaning off ECMO	Clearance of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
Pharmacokinetic parameter: Volume of distribution	Between day0 to day3 after weaning off ECMO	Volume of distribution of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
Serum or plasma concentration	Between day0 to day3 after weaning off ECMO	Serum or plasma concentration of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl

Trial Locations

Locations (1)

Department of Thoracic and Cardiovascular Surgery, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of