CClinicalTrials.gg
Sign In
Status unknownNCT05406492Updated Jun 27, 2022

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

An observational study in Pharmacokinetics and Extracorporeal Membrane Oxygenation, sponsored by Gachon University Gil Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-06-27.

Sponsored by Gachon University Gil Medical Center · Observational

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pharmacokinetics
  • Extracorporeal Membrane Oxygenation

Keywords

  • Extracorporeal Membrance Oxygenation
  • Pharmacokinetic medeling
  • Antiplatelet agents
  • Sedatives
  • Antibiotics
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Target follow-up
10 Days
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Patients udergoing ECMO

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

    Other: Residual blood

Interventions

  • OtherResidual 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.).

05

What researchers measure

Primary outcomes

  1. Pharmacokinetic parameters

    Volume of distribution

    Time frame: Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO

  2. Pharmacokinetic parameters

    Clearance

    Time frame: Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO

  3. Pharmacokinetic parameters

    Absorption rate (if oral drugs)

    Time frame: Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO

06

Study locations

1 of 1 sites recruiting
  • Gacheon University Gil Medical Center
    Incheon, 21565, Korea, Republic of
    Recruiting
07

References and documents

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. PubMed 22520488 ↗
  • 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. PubMed 25032748 ↗
  • 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. PubMed 23190792 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT05406492
Lead sponsor
Gachon University Gil Medical Center
Collaborators
Yonsei University
Responsible party
Jin Wi (Director of Heart Intensive Care Unit, Gachon University Gil Medical Center) — Principal investigator
First posted
Jun 6, 2022
Start date
Jul 16, 2019
Primary completion
Jul 15, 2024 (estimated)
Completion
Jul 15, 2024 (estimated)
Last update
Jun 27, 2022

Study contacts

Jin Wi, Prof
Contact
caesar@gilhospital.com
+82 32-460-3663

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Gachon University Gil Medical Center

Start the discussion