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OpenTrials
Completed

NCT Number: 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)

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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Key information

Conditions

Cardiac Dysfunction

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.).

Primary outcomes

  1. Serum or plasma concentration

    Time frame: 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

  2. Pharmacokinetic parameter: Cmax

    Time frame: Between day0 to day3 after removing ECMO

  3. Pharmacokinetic parameter: Tmax

    Time frame: Between day0 to day3 after removing ECMO

  4. Clearance

    Time frame: Between day0 to day3 after removing ECMO

  5. volume of distribution

    Time frame: Between day0 to day3 after removing ECMO

  6. absorption rate constant

    Time frame: Between day0 to day3 after removing ECMO

    absorption rate constant (if the drug is orally administered),

  7. elimination half life

    Time frame: Between day0 to day3 after removing ECMO

  8. area under the curve (AUC)

    Time frame: Between day0 to day3 after removing ECMO

    area under the curve (AUC) (if possible)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Oct 20, 2015
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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