Pharmacokinetics in Extracorporeal Membrane Oxygenation

NCT ID: NCT03766282

Last Updated: 2018-12-06

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

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2021-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Extracorporeal Membrane Oxygenation Pharmacokinetics

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

ECMO

Intervention Type DEVICE

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

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.

ECMO

Intervention Type DEVICE

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

Interventions

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ECMO

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

Intervention Type DEVICE

Other Intervention Names

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Extracorporeal membrane oxygenation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qingyuan Zhan

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chen Wang

Role: STUDY_CHAIR

China-Japan Friendship Hospital

Locations

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China-Japan Friendship hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qingyuan Zhan, MD

Role: CONTACT

13683598417

Min Li, MD

Role: CONTACT

13683598417

Facility Contacts

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Chen Wang, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 32816724 (View on PubMed)

Other Identifiers

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2017-2-QN-15

Identifier Type: -

Identifier Source: org_study_id

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