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)

Cardiac Dysfunction Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02581280
• Other study ID #: 4-2014-0919
• Status: Completed
• Start date: December 2014
• Est. completion date: January 31, 2019

Study information

• Verified date: November 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Dysfunction

Intervention

Other:
• Residual 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.).

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum or plasma concentration	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	Between day0 to day3 after removing ECMO
Primary	Pharmacokinetic parameter: Cmax		Between day0 to day3 after removing ECMO
Primary	Pharmacokinetic parameter: Tmax		Between day0 to day3 after removing ECMO
Primary	Clearance		Between day0 to day3 after removing ECMO
Primary	volume of distribution		Between day0 to day3 after removing ECMO
Primary	absorption rate constant	absorption rate constant (if the drug is orally administered),	Between day0 to day3 after removing ECMO
Primary	elimination half life		Between day0 to day3 after removing ECMO
Primary	area under the curve (AUC)	area under the curve (AUC) (if possible)	Between day0 to day3 after removing ECMO