Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
NCT ID: NCT04674657
Last Updated: 2020-12-19
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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UNKNOWN
30 participants
OBSERVATIONAL
2018-09-03
2021-09-30
Brief Summary
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Secondary Objectives:
Develop Population PK models of anti-infectives, including voriconazole, posaconazole and caspofungin in critically ill patients on ECMO
Develop Physiological-Based PK (PBPK) model of anti-infectives, including: voriconazole, posaconazole and caspofungin in critically ill patients on ECMO
Study population: Critically ill patients on ECMO
Methodology: Observational study to determine whether ECMO alters the PK of anti-infectives, by developing PK models
This is a non-interventional descriptive study in that the anti-infective drug selection and dosing will be at the discretion of the clinician, based on the clinical context and unit guidelines. Doses will be reconstituted and administered as per local hospital protocols in line with patient's routine care. Patients will be asked to provide additional blood samples over the course of the anti-infective dosing schedule, these samples will be taken from existing arterial lines to help guide treatment in future patients on ECMO receiving these anti-infectives.
Detailed Description
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Blood samples will be drawn from an existing arterial line and collected in 3 ml tubes with Lithium Heparin anticoagulant.
All patients will be sampled over a single dosing period on the second day of Extra-Corporeal Membrane Oxygenation (ECMO) treatment, or of an antibiotic course where antibiotics are commenced whilst the patient is on ECMO. Where possible, sampling during one extra dosing interval will occur on days 4-8 of ECMO treatment and/or prior to the next tubing change. Where two or more anti-infectives of interest are prescribed for one patient, collect data on timing of administration for both drugs and sample according to the antibiotic with the longer dosing interval.
Blood samples (2ml) will be collected from an existing arterial line at the following time points 0 (pre-starting infusion, pre-Nasogastric (NG)/Oral (PO) dose), 1 (end of infusion or 1hour post NG/PO dose), 2, 3, 4, 8 and either 12 (for twice daily regimen) or 24 (for once daily regimen) hours on the second day of ECMO.
Where a patient is receiving medications where a validated drug assay exists in addition to the study drug (such as other anti-infectives), analysis of the additional therapy will also be attempted where practical.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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caspofungin
Adult critically ill patients on ECMO receiving caspofungin therapy
blood drug concentration
blood drug concentration
posaconazole
Adult critically ill patients on ECMO receiving posaconazole therapy
blood drug concentration
blood drug concentration
Interventions
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blood drug concentration
blood drug concentration
Eligibility Criteria
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Inclusion Criteria
2. Currently undergoing ECMO for respiratory +/- cardiac dysfunction
3. Clinical indication for the anti-infectives, including voriconazole, posaconazole and caspofungin
Exclusion Criteria
2. Pregnant women
18 Years
90 Years
ALL
No
Sponsors
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Royal Brompton & Harefield NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Anna Reed
Role: PRINCIPAL_INVESTIGATOR
Royal Brompton and Harefield NHS Foundation Trust
Locations
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Royal Brompton & Harefield NHS Foundation Trust
Harefield, Middlesex, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Haifa Lyster
Role: primary
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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18/LO/0691
Identifier Type: -
Identifier Source: org_study_id