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)

Completed

• Conditions: Cardiac Dysfunction
• Interventions: Other: Residual blood

• Registration Number: NCT02581280
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2015-10-18
• Study First Posted: 2015-10-20
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-08
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
On ECMO	Residual blood	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	Residual blood	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

Primary Outcome Measures

Name	Time	Method
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
volume of distribution	Between day0 to day3 after removing ECMO
elimination half life	Between day0 to day3 after removing ECMO
Clearance	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),
area under the curve (AUC)	Between day0 to day3 after removing ECMO	area under the curve (AUC) (if possible)

Trial Locations

Locations (1)

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of