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Pharmacokinetics in Extracorporeal Membrane Oxygenation

Sponsor
China-Japan Friendship Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03766282
Collaborator
(none)
50
Enrollment
1
Location
51.9
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of the present study is to investigate the risk factors that affect drug pharmacokinetic (PK) during extracorporeal membrane oxygenation (ECMO). To advance understanding of PK variance and improve the patients outcomes during ECMO.

Condition or Disease Intervention/Treatment Phase
  • Device: ECMO

Detailed Description

Ex vivo experiments for drug stability testing and ECMO circuits testing in animal models.PK studies in healthy animals and critically ill animal models with or without ECMO to define the PK alterations. Clinical PK studies in critically ill patients on ECMO.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Pharmacokinetics of Antibiotics, Sedative and Analgesic During Extracorporeal Membrane Oxygenation
Actual Study Start Date :
Sep 1, 2017
Anticipated Primary Completion Date :
Jul 1, 2020
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Animal study

Critically ill animal on ECMO. PK data from critically ill animal on ECMO will be compared with data from controls and healthy animal on ECMO.

Device: ECMO
Extracorporeal membrane oxygenation (ECMO) temporarily supports patients with severe cardio-respiratory failure
Other Names:
  • Extracorporeal membrane oxygenation

    		•
    Clinical study

    To describe variation of plasma concentration of drugs in patients receiving ECMO, as compared with patients without ECMO.And develop population PK model for ECMO patients.

    Device: ECMO
    Extracorporeal membrane oxygenation (ECMO) temporarily supports patients with severe cardio-respiratory failure
    Other Names:
  • Extracorporeal membrane oxygenation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The median observed peak concentration(Cmax) [one-dose period]

      Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs

    2. The median observed through concentration(Cmin) [one-dose period]

      Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs

    3. Volume of distribution(Vd) [one-dose period]

      PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0

    4. Area under the plasma concentration versus time curve (AUC) [one-dose period]

      PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0

    5. Inter-compartmental clearance (Q) [one-dose period]

      PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0

    6. Clearance(CL) [one-dose period]

      PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0

    Secondary Outcome Measures

    1. Development of strategies for drug administration in critically ill patients receiving ECMO [one-dose period]

      PK models for study drugs using a non-linear mixed effects modeling approach.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients who are undergoing ECMO for respiratory and or cardiac dysfunction

    • Clinical indication for the antibiotics

    • Clinical indication for the sedatives and analgesics

    Exclusion Criteria:

    • No consent

    • Known allergy to study drug

    • Pregnancy

    • Massive fluid resuscitation (>50% blood volume transfused) in the previous 8 hours.

    • Therapeutic plasma exchange in the preceding 24 hours

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 China-Japan Friendship hospital Beijing Beijing China 100028

    Sponsors and Collaborators

    • China-Japan Friendship Hospital

    Investigators

    • Study Chair: Chen Wang, China-Japan Friendship Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qingyuan Zhan, Prof., China-Japan Friendship Hospital
    ClinicalTrials.gov Identifier:
    NCT03766282
    Other Study ID Numbers:
    • 2017-2-QN-15
    First Posted:
    Dec 6, 2018
    Last Update Posted:
    Dec 6, 2018
    Last Verified:
    Dec 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Qingyuan Zhan, Prof., China-Japan Friendship Hospital
    Pharmacokinetics
    extracorporeal membrane oxygenation

    Study Results

    No Results Posted as of Dec 6, 2018