NCT03766282

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.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

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

September 1, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

December 6, 2018

Status Verified

December 1, 2018

Enrollment Period

2.8 years

First QC Date

December 4, 2018

Last Update Submit

December 5, 2018

Conditions

Extracorporeal Membrane OxygenationPharmacokinetics

Keywords

Pharmacokineticsextracorporeal membrane oxygenation

Outcome Measures

Primary Outcomes (6)

  • The median observed peak concentration(Cmax)

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

    one-dose period

  • The median observed through concentration(Cmin)

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

    one-dose period

  • Volume of distribution(Vd)

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

    one-dose period

  • Area under the plasma concentration versus time curve (AUC)

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

    one-dose period

  • Inter-compartmental clearance (Q)

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

    one-dose period

  • Clearance(CL)

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

    one-dose period

Secondary Outcomes (1)

  • Development of strategies for drug administration in critically ill patients receiving ECMO

    one-dose period

Study Arms (2)

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

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

Interventions

ECMODEVICE

Extracorporeal membrane oxygenation (ECMO) temporarily supports patients with severe cardio-respiratory failure

Also known as: Extracorporeal membrane oxygenation
Animal studyClinical study

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are undergoing ECMO

You may qualify if:

  • Patients who are undergoing ECMO for respiratory and or cardiac dysfunction
  • Clinical indication for the antibiotics
  • Clinical indication for the sedatives and analgesics

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship hospital

Beijing, Beijing Municipality, 100028, China

RECRUITING

Related Publications (1)

  • Wang Q, Zhang Z, Liu D, Chen W, Cui G, Li P, Zhang X, Li M, Zhan Q, Wang C. Population Pharmacokinetics of Caspofungin among Extracorporeal Membrane Oxygenation Patients during the Postoperative Period of Lung Transplantation. Antimicrob Agents Chemother. 2020 Oct 20;64(11):e00687-20. doi: 10.1128/AAC.00687-20. Print 2020 Oct 20.

    PMID: 32816724DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples drawn from an existing arterial line and collect in 2-4ml tubes. Centrifuged at 3000 rpm for 10 minutes before frozen at -80℃.

MeSH Terms

Interventions

Extracorporeal Membrane Oxygenation

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Chen Wang

    China-Japan Friendship Hospital

    STUDY CHAIR

Central Study Contacts

Qingyuan Zhan, MD

CONTACT

13683598417zhanqy0915@163.com

Min Li, MD

CONTACT

13683598417qlyy_limin@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

December 4, 2018

First Posted

December 6, 2018

Study Start

September 1, 2017

Primary Completion

July 1, 2020

Study Completion

December 30, 2021

Last Updated

December 6, 2018

Record last verified: 2018-12

Locations

CN(1)