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

Study Overview
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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.

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

Conditions
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Pediatric Patients Receiving Venoarterial Extracorporeal Membrane Oxygenation

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| On ECMO<br>patients who is receiving vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl during ECMO support. | |
| Off ECMO<br>patients who is receiving vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl after weaning off ECMO. | |

What is the study measuring?
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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 |