Clinical trial NCT02581280: Population Pharmacokinetics of Teicoplanin, Levofloxacin, Piperacillin/Tazobactam, Meropenem, Vancomycin, Remifentanil, Cefepime, Cefpirome, Sufentanil, Midazolam, Clopidogrel, Ticagrelor, Prasugrel During Veno-arterial Extracorporeal Membrane Oxygenation (VA ECMO)
Official title: Population Pharmacokinetics of Teicoplanin, Levofloxacin, Piperacillin/Tazobactam, Meropenem, Vancomycin, Remifentanil, Cefepime, Cefpirome, Sufentanil, Midazolam, Clopidogrel, Ticagrelor, Prasugrel During Veno-arterial Extracorporeal Membrane Oxygenation (VA ECMO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Dysfunction
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 56
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 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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* patient who are ≥ 19 years old and receiving VA ECMO in Severance Hospital, Yonsei University Health System.
* patient who are receiving one of these drugs: 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
* patients who are agreed to participate in this study

Exclusion Criteria:

* patients who are pregnant
* patients who are receiving drugs that could affect study drug's concentration due to drug-drug interaction.

Primary outcomes:
measure: Serum or plasma concentration
timeFrame: Between day0 to day3 after removing ECMO
measure: Pharmacokinetic parameter: Cmax
timeFrame: Between day0 to day3 after removing ECMO
measure: Pharmacokinetic parameter: Tmax
timeFrame: Between day0 to day3 after removing ECMO
measure: Clearance
timeFrame: Between day0 to day3 after removing ECMO
measure: volume of distribution
timeFrame: Between day0 to day3 after removing ECMO
measure: absorption rate constant
timeFrame: Between day0 to day3 after removing ECMO
measure: elimination half life
timeFrame: Between day0 to day3 after removing ECMO
measure: area under the curve (AUC)
timeFrame: Between day0 to day3 after removing ECMO
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Study officials:
affiliation: Severance Hospital
name: Jin Wi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.