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NCT05406492 Clinical Trial

Population PK of Antibiotics, Sedative and Analgesics, and Antiplatelet Drugs During ECMO

Pharmacokinetics Clinical Trial

Official title:
Population Pharmacokinetics of Antibiotics, Sedative and Analgesics, and Antiplatelet Agents During Extracorporeal Membrane Oxygenation (ECMO)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05406492
Other study ID # GDIRB2019-228
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 16, 2019
Est. completion date July 15, 2024

Study information
Verified date June 2022
Source Gachon University Gil Medical Center
Contact Jin Wi, Prof
Phone +82 32-460-3663
Email caesar@gilhospital.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to optimize the dosage regimen of drugs in patients during during Extracorporeal Membrane Oxygenation (ECMO) by population pharmacokinetic modeling.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date July 15, 2024
Est. primary completion date July 15, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Patients who are taking levofloxacin, meropenem, vancomycin, cefepime, midalzolam, dexmedetomidine, propofol, clopidogrel, ticagrelor, or prasugrel while underdoing Extracorporeal Membrane Oxygenation Exclusion Criteria: - Pregnant women - Receiving a therapy that can affect blood concentration due to a drug-drug interaction with levofloxacin, meropenem, vancomycin, cefepime, midalzolam, dexmedetomidine, propofol, clopidogrel, ticagrelor, or prasugrel

Study Design

Related Conditions & MeSH terms

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 Gacheon University Gil Medical Center Incheon

Sponsors (2)
Lead Sponsor Collaborator
Gachon University Gil Medical Center Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Shekar K, Fraser JF, Smith MT, Roberts JA. Pharmacokinetic changes in patients receiving extracorporeal membrane oxygenation. J Crit Care. 2012 Dec;27(6):741.e9-18. doi: 10.1016/j.jcrc.2012.02.013. Epub 2012 Apr 18. Review. — View Citation

Shekar K, Mullany DV, Thomson B, Ziegenfuss M, Platts DG, Fraser JF. Extracorporeal life support devices and strategies for management of acute cardiorespiratory failure in adult patients: a comprehensive review. Crit Care. 2014 May 9;18(3):219. doi: 10.1186/cc13865. Review. — View Citation

Shekar K, Roberts JA, Welch S, Buscher H, Rudham S, Burrows F, Ghassabian S, Wallis SC, Levkovich B, Pellegrino V, McGuinness S, Parke R, Gilder E, Barnett AG, Walsham J, Mullany DV, Fung YL, Smith MT, Fraser JF. ASAP ECMO: Antibiotic, Sedative and Analgesic Pharmacokinetics during Extracorporeal Membrane Oxygenation: a multi-centre study to optimise drug therapy during ECMO. BMC Anesthesiol. 2012 Nov 28;12:29. doi: 10.1186/1471-2253-12-29. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetic parameters Volume of distribution Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO
Primary Pharmacokinetic parameters Clearance Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO
Primary Pharmacokinetic parameters Absorption rate (if oral drugs) Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO
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