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

NCT ID: NCT04701099

Last Updated: 2021-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-07

Study Completion Date

2023-04-30

Brief Summary

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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

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Conditions

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Pediatric Patients Receiving Venoarterial Extracorporeal Membrane Oxygenation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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On ECMO

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

No interventions assigned to this group

Off ECMO

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu Rim Shin, Assistant Professor

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

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Department of Thoracic and Cardiovascular Surgery, Yonsei University Health System

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yu Rim Shin, Assistant Professor

Role: CONTACT

82-2-2228-8480

Facility Contacts

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Yu Rim Shin, Assistant Professor

Role: primary

82-2-2228-8480

Other Identifiers

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4-2020-0182

Identifier Type: -

Identifier Source: org_study_id

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