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

NCT ID: NCT05406492

Last Updated: 2022-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-16

Study Completion Date

2024-07-15

Brief Summary

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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

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Conditions

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Pharmacokinetics Extracorporeal Membrane Oxygenation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients udergoing ECMO

Population who have been taking antibiotics or antiplatelets or sedatives/analgesics during Extracorporeal Membrane Oxygenation

Residual blood

Intervention Type OTHER

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.).

Interventions

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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.).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role collaborator

Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jin Wi

Director of Heart Intensive Care Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gacheon University Gil Medical Center

Incheon, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jin Wi, Prof

Role: CONTACT

+82 32-460-3663

Facility Contacts

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Jin Wi, Prof

Role: primary

+82 32-460-3663

References

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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.

Reference Type BACKGROUND
PMID: 22520488 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25032748 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23190792 (View on PubMed)

Other Identifiers

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GDIRB2019-228

Identifier Type: -

Identifier Source: org_study_id

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