Clinical trial NCT05406492: Population PK of Antibiotics, Sedative and Analgesics, and Antiplatelet Drugs During ECMO
Official title: Population Pharmacokinetics of Antibiotics, Sedative and Analgesics, and Antiplatelet Agents During Extracorporeal Membrane Oxygenation (ECMO)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pharmacokinetics
Extracorporeal Membrane Oxygenation
Keywords: Extracorporeal Membrance Oxygenation
Pharmacokinetic medeling
Antiplatelet agents
Sedatives
Antibiotics
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
Collaborators: name: Yonsei University
First posted: 2022-06-06
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are taking levofloxacin, meropenem, vancomycin, cefepime, midalzolam, dexmedetomidine, propofol, clopidogrel, ticagrelor, or prasugrel while underdoing Extracorporeal Membrane Oxygenation

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetic parameters
timeFrame: Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO
measure: Pharmacokinetic parameters
timeFrame: Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO
measure: Pharmacokinetic parameters
timeFrame: Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gacheon University Gil Medical Center
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.