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Extracorporeal membrane oxygenation (ECMO) is the device which increases the supply of oxygen to the body tissues in vitro and to assist in heart and lung function. Venoarterial (VA) ECMO is used in patients with cardiogenic shock, cardiac arrest, ventricular arrhythmia and is able to secure a time to self-recovery by reducing the excessive stimulation applied to the heart. However, in ECMO patients, pharmacokinetics of drugs are changing such as increased volume of distribution (Vd) or decreased clearance (CL). For this reason, it is hard to provide the best treatment in ECMO patients. The study is to evaluate whether the PK of drugs is influenced by VA ECMO and to recommend the optimal dosing strategies for proposed drugs in adult patients receiving VA ECMO.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| On ECMO | patients who are concomitantly receiving teicoplanin or levofloxacin or piperacillin/tazobactam or meropenem or vancomycin or remifentanil or cefepime or cefpirome or sufentanil or midazolam or clopidogrel or ticagrelor or prasugrel during ECMO |
| |
| Off ECMO | patients who are concomitantly receiving teicoplanin or levofloxacin or piperacillin/tazobactam or meropenem or vancomycin or remifentanil or cefepime or cefpirome or sufentanil or midazolam or clopidogrel or ticagrelor or prasugrel after removing ECMO |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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.). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum or plasma concentration | Serum or plasma concentration of teicoplanin or levofloxacin or piperacillin/tazobactam or meropenem or vancomycin or remifentanil or cefepime or cefpirome or sufentanil or midazolam or clopidogrel or ticagrelor or prasugrel | Between day0 to day3 after removing ECMO |
| Pharmacokinetic parameter: Cmax | Between day0 to day3 after removing ECMO | |
| Pharmacokinetic parameter: Tmax | Between day0 to day3 after removing ECMO | |
| Clearance | Between day0 to day3 after removing ECMO | |
| volume of distribution | Between day0 to day3 after removing ECMO | |
| absorption rate constant | absorption rate constant (if the drug is orally administered), | Between day0 to day3 after removing ECMO |
| elimination half life | Between day0 to day3 after removing ECMO | |
| area under the curve (AUC) | area under the curve (AUC) (if possible) | Between day0 to day3 after removing ECMO |
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Inclusion Criteria:
Exclusion Criteria:
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Patients over the age of 19 who are receiving teicoplanin or levofloxacin or piperacillin/tazobactam or remifentanil or sufentanil or clopidogrel or ticagrelor while using VA ECMO in Severance Hospital, Yonsei University Health System.
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| Name | Affiliation | Role |
|---|---|---|
| Jin Wi, MD | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine | Seoul | 03722 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41325279 | Derived | Kim H, Jin BH, Yang S, Hahn J, Kang S, Kim D, Lee H, Kwack H, Chae SU, Bae SK, Wi J, Chang MJ. Effect of Extracorporeal Membrane Oxygenation Flow Rate on Midazolam Clearance: A Population Pharmacokinetic Study. Anesthesiology. 2026 Feb 1;144(2):485-488. doi: 10.1097/ALN.0000000000005811. Epub 2025 Nov 25. No abstract available. | |
| 34937189 |
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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.). After ECMO device is removed, residual arterial blood samples(1~2 mls) at each sampling time are collected and drug concentrations are assayed.
| Hahn J, Min KL, Kang S, Yang S, Park MS, Wi J, Chang MJ. Population Pharmacokinetics and Dosing Optimization of Piperacillin-Tazobactam in Critically Ill Patients on Extracorporeal Membrane Oxygenation and the Influence of Concomitant Renal Replacement Therapy. Microbiol Spectr. 2021 Dec 22;9(3):e0063321. doi: 10.1128/Spectrum.00633-21. Epub 2021 Dec 22. |
| 32122899 | Derived | Kang S, Jang JY, Hahn J, Kim D, Lee JY, Min KL, Yang S, Wi J, Chang MJ. Dose Optimization of Cefpirome Based on Population Pharmacokinetics and Target Attainment during Extracorporeal Membrane Oxygenation. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e00249-20. doi: 10.1128/AAC.00249-20. Print 2020 Apr 21. |
| 31288863 | Derived | Hahn J, Yang S, Min KL, Kim D, Jin BH, Park C, Park MS, Wi J, Chang MJ. Population pharmacokinetics of intravenous sufentanil in critically ill patients supported with extracorporeal membrane oxygenation therapy. Crit Care. 2019 Jul 9;23(1):248. doi: 10.1186/s13054-019-2508-4. |
| 28674057 | Derived | Wi J, Noh H, Min KL, Yang S, Jin BH, Hahn J, Bae SK, Kim J, Park MS, Choi D, Chang MJ. Population Pharmacokinetics and Dose Optimization of Teicoplanin during Venoarterial Extracorporeal Membrane Oxygenation. Antimicrob Agents Chemother. 2017 Aug 24;61(9):e01015-17. doi: 10.1128/AAC.01015-17. Print 2017 Sep. |