Population PK of Antibiotics, Sedative and Analgesics, and Antiplatelet Drugs During ECMO

NCT05406492 — Unknown, 10 participants, Gachon University Gil Medical Center

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Population Pharmacokinetics of Antibiotics, Sedative and Analgesics, and Antiplatelet Agents During Extracorporeal Membrane Oxygenation (ECMO)

Registry	NCT05406492
Status	Unknown
Study type	Observational
Enrollment	10 (Estimated)
Sponsor	Gachon University Gil Medical Center (Other); collaborators: Yonsei University
Conditions	Pharmacokinetics, Extracorporeal Membrane Oxygenation
Interventions	Residual blood (Other)
Dates	start 2019-07-16, primary completion 2024-07-15 (estimated), completion 2024-07-15 (estimated), first posted 2022-06-06, last updated 2022-06-27
Locations	1 site in South Korea

-Summary

The purpose of this study is to optimize the dosage regimen of drugs in patients during during Extracorporeal Membrane Oxygenation (ECMO) by population pharmacokinetic modeling.

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+Arms and interventions

Arm	Type	Interventions	Description
Patients udergoing ECMO		Other: Residual blood	Population who have been taking antibiotics or antiplatelets or sedatives/analgesics during Extracorporeal Membrane Oxygenation

Residual blood (Other): Residual blood samples(1\~2 cc) at each sampling time are collected from all subjects while using ECMO for drug concentration assays(LC-MS/MS etc.).

+Outcome measures

Primary outcomes

Pharmacokinetic parameters [Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO]: Volume of distribution
Pharmacokinetic parameters [Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO]: Clearance
Pharmacokinetic parameters [Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO]: Absorption rate (if oral drugs)

+Eligibility

Sex: All, ages: 19 Years to any

Inclusion Criteria:

* Patients who are taking levofloxacin, meropenem, vancomycin, cefepime, midalzolam, dexmedetomidine, propofol, clopidogrel, ticagrelor, or prasugrel while underdoing Extracorporeal Membrane Oxygenation

Exclusion Criteria:

* Pregnant women
* Receiving a therapy that can affect blood concentration due to a drug-drug interaction with levofloxacin, meropenem, vancomycin, cefepime, midalzolam, dexmedetomidine, propofol, clopidogrel, ticagrelor, or prasugrel

+Locations (1)

Facility	City	Country	Status
Gacheon University Gil Medical Center	Incheon	South Korea	Recruiting

+Publications

Shekar K, Fraser JF, Smith MT, Roberts JA. Pharmacokinetic changes in patients receiving extracorporeal membrane oxygenation. J Crit Care. 2012 Dec;27(6):741.e9-18. doi: 10.1016/j.jcrc.2012.02.013. Epub 2012 Apr 18. PMID 22520488
Shekar K, Mullany DV, Thomson B, Ziegenfuss M, Platts DG, Fraser JF. Extracorporeal life support devices and strategies for management of acute cardiorespiratory failure in adult patients: a comprehensive review. Crit Care. 2014 May 9;18(3):219. doi: 10.1186/cc13865. PMID 25032748
Shekar K, Roberts JA, Welch S, Buscher H, Rudham S, Burrows F, Ghassabian S, Wallis SC, Levkovich B, Pellegrino V, McGuinness S, Parke R, Gilder E, Barnett AG, Walsham J, Mullany DV, Fung YL, Smith MT, Fraser JF. ASAP ECMO: Antibiotic, Sedative and Analgesic Pharmacokinetics during Extracorporeal Membrane Oxygenation: a multi-centre study to optimise drug therapy during ECMO. BMC Anesthesiol. 2012 Nov 28;12:29. doi: 10.1186/1471-2253-12-29. PMID 23190792