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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Rim Shin, Assistant Professor | Contact | 82-2-2228-8480 | yull0629@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Yu Rim Shin, Assistant Professor | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Thoracic and Cardiovascular Surgery, Yonsei University Health System | Recruiting | Seoul | South Korea |
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At each sampling time, an arterial blood sample (1 to 2 mL) is collected from all subjects during ECMO support and after weaning off ECMO for drug concentration assay (LC-MS/MS, etc.).