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

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Patients Receiving Venoarterial Extracorporeal Membrane Oxygenation

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Yu Rim Shin, Assistant Professor; Phone Number: 82-2-2228-8480; Email: yull0629@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Department of Thoracic and Cardiovascular Surgery, Yonsei University Health System
    • Contact: Yu Rim Shin, Assistant Professor; Phone Number: 82-2-2228-8480; Email: yull0629@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients under the age of 19 who are receiving vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl while using VA ECMO in Severance Hospital, Yonsei University Health System.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
On ECMO; patients who is receiving vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl during ECMO support.
Off ECMO; patients who is receiving vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl after weaning off ECMO.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Yu Rim Shin, Assistant Professor, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2020
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: January 3, 2021
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): January 8, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 4-2020-0182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No