Cardiac Dysfunction
Conditions
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.
Interventions
OTHERResidual blood
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.).
Sponsors
Yonsei University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum or plasma concentration | Between day0 to day3 after removing ECMO | 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 |
| 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 | Between day0 to day3 after removing ECMO | absorption rate constant (if the drug is orally administered), |
| elimination half life | Between day0 to day3 after removing ECMO | — |
| area under the curve (AUC) | Between day0 to day3 after removing ECMO | area under the curve (AUC) (if possible) |
Countries
South Korea
Outcome results
None listed