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

• Conditions: Pharmacokinetics; Extracorporeal Membrane Oxygenation
• Interventions: Other: Residual blood

• Registration Number: NCT05406492
• Lead Sponsor: Gachon University Gil Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-16
• Status Verified: 2022-06
• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-02
• Study First Posted: 2022-06-06
• Last Update Submitted: 2022-06-21
• Last Update Posted: 2022-06-27
• Primary Completion: 2024-07-15
• Study Completion: 2024-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients udergoing ECMO	Residual blood	Population who have been taking antibiotics or antiplatelets or sedatives/analgesics during Extracorporeal Membrane Oxygenation

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters	Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO	Absorption rate (if oral drugs)

Trial Locations

Locations (1)

Gacheon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of