Population Pharmacokinetics of L-AmB in Chinese Patients Assisted by Extracorporeal Membrane Pulmonary Oxygenation (ECMO)
NCT ID: NCT06754436
Last Updated: 2024-12-31
Study Results
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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NOT_YET_RECRUITING
PHASE4
30 participants
INTERVENTIONAL
2025-01-10
2026-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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L-AmB group
To establish and validate a population pharmacokinetic model for L-AmB in patients with severe invasive fungal infections treated undergoing ECMO-assisted therapy.
Determination of blood drug concentration
Collecting blood samples from patients and determining blood drug concentrations. Patients were intravenously titrated after 3 doses of maintenance dose titration of L-AmB. The time points of sample collecting were 30 minutes before and 1, 2, 3, 6, 9, 12, 16, 20, 24 hours after administration. Then, the blood concentrations were determined according to the established method.
Interventions
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Determination of blood drug concentration
Collecting blood samples from patients and determining blood drug concentrations. Patients were intravenously titrated after 3 doses of maintenance dose titration of L-AmB. The time points of sample collecting were 30 minutes before and 1, 2, 3, 6, 9, 12, 16, 20, 24 hours after administration. Then, the blood concentrations were determined according to the established method.
Eligibility Criteria
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Inclusion Criteria
* Requiring ECOM assistance.
* Age 18 years.
Exclusion Criteria
* Pregnancy.
* Expected survival time \<24 hours.
* Lack of necessary data on patient demographics physiopathology, and clinical status.
18 Years
ALL
No
Sponsors
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Beijing Anzhen Hospital
OTHER
Responsible Party
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Lin Yang
Director of pharmacy department of Beijing Anzhen Hospital
Locations
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Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Yang Lin, PhD
Role: primary
Other Identifiers
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ANZHEN HOSPITOL-LY-05
Identifier Type: -
Identifier Source: org_study_id