NCT05406492

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2019

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

5 years

First QC Date

June 2, 2022

Last Update Submit

June 21, 2022

Conditions

PharmacokineticsExtracorporeal Membrane Oxygenation

Keywords

Extracorporeal Membrance OxygenationPharmacokinetic medelingAntiplatelet agentsSedativesAntibiotics

Outcome Measures

Primary Outcomes (3)

  • Pharmacokinetic parameters

    Volume of distribution

    Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO

  • Pharmacokinetic parameters

    Clearance

    Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO

  • Pharmacokinetic parameters

    Absorption rate (if oral drugs)

    Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO

Study Arms (1)

Patients udergoing ECMO

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

Other: Residual blood

Interventions

Residual bloodOTHER

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.).

Patients udergoing ECMO

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are taking levofloxacin, meropenem, vancomycin, cefepime, midalzolam, dexmedetomidine, propofol, clopidogrel, ticagrelor, or prasugrel while underdoing Extracorporeal Membrane Oxygenation

You may qualify if:

  • Patients who are taking levofloxacin, meropenem, vancomycin, cefepime, midalzolam, dexmedetomidine, propofol, clopidogrel, ticagrelor, or prasugrel while underdoing Extracorporeal Membrane Oxygenation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gacheon University Gil Medical Center

Incheon, 21565, South Korea

RECRUITING

Related 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.

    PMID: 22520488BACKGROUND

  • 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.

    PMID: 25032748BACKGROUND

  • 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.

    PMID: 23190792BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Residual whole blood

Central Study Contacts

Jin Wi, Prof

CONTACT

+82 32-460-3663caesar@gilhospital.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Heart Intensive Care Unit

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 6, 2022

Study Start

July 16, 2019

Primary Completion

July 15, 2024

Study Completion

July 15, 2024

Last Updated

June 27, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)