Population PK of Antibiotics, Sedative and Analgesics, and Antiplatelet Drugs During ECMO
Sponsor
Gachon University Gil Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05406492
Collaborator
Yonsei University (Other)
10
1
60
0.2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
10 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Population Pharmacokinetics of Antibiotics, Sedative and Analgesics, and Antiplatelet Agents During Extracorporeal Membrane Oxygenation (ECMO)
Actual Study Start Date
:
Jul 16, 2019
Anticipated Primary Completion Date
:
Jul 15, 2024
Anticipated Study Completion Date
:
Jul 15, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients udergoing ECMO Population who have been taking antibiotics or antiplatelets or sedatives/analgesics during Extracorporeal Membrane Oxygenation |
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.).
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetic parameters [Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO]
Volume of distribution
- Pharmacokinetic parameters [Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO]
Clearance
- Pharmacokinetic parameters [Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO]
Absorption rate (if oral drugs)
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gacheon University Gil Medical Center | Incheon | Korea, Republic of | 21565 |
Sponsors and Collaborators
- Gachon University Gil Medical Center
- Yonsei University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
Responsible Party:
Jin Wi,
Director of Heart Intensive Care Unit,
Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT05406492
Other Study ID Numbers:
- GDIRB2019-228
First Posted:
Jun 6, 2022
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Jin Wi,
Director of Heart Intensive Care Unit,
Gachon University Gil Medical Center