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Trial registered on ANZCTR
Registration number
ACTRN12625000178448p
Ethics application status
Submitted, not yet approved
Date submitted
29/01/2025
Date registered
14/02/2025
Date last updated
14/02/2025
Date data sharing statement initially provided
14/02/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
An open label pilot study of 30% sodium asCOrbate aS OSMOtherapy in patientS with traumatic brain injury and raised intracranial pressure- The COSMOS study
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Scientific title
An open label pilot feasibility study of 30% sodium asCOrbate aS OSMOtherapy in patientS with traumatic brain injury and raised intracranial pressure
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Secondary ID [1]
313838
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
traumatic brain injury
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traumatic intracranial hypertension
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Condition category
Condition code
Neurological
332998
332998
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Enrolled participants will become eligible for delivery of the intervention if the intracranial pressure (ICP) is equal or more 20 mmHg for 5 minutes despite adequate sedation, positioning, and physiological optimisation and/or the treating clinicians believe that it is necessary to provide immediate treatment for raised ICP.
Dosing regimen
A 60 ml of neat 30% sodium ascorbate (18 grams) will be infused through a dedicated lumen of a central venous catheter over 10 minutes. If the ICP remains equal or above 20 mmHg for more 5 minutes 60 minutes post the first dose, a second bolus dose of 40 mL of neat 30% sodium ascorbate (12 grams) will be infused through a dedicated lumen of a central venous catheter over 10 minutes.
Patients will only receive sodium ascorbate once during their ICU admission if their ICP increases above 20 mmHg. The duration of administration is maximum of 20 minutes. Any staff providing the intervention (Either ICU nurse or the treating physician) will receive protocol training. Intervention administration will be recorded in the medical records and used to monitor protocol adherence.
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Intervention code [1]
330422
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Treatment: Drugs
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Comparator / control treatment
NA
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Feasibility
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Assessment method [1]
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Time from meeting eligibility criteria to first dose of sodium ascorbate Data will be collected from medical records
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Timepoint [1]
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ICU admission
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Secondary outcome [1]
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Feasibility
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Assessment method [1]
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Recruitment rate Data will be collected from medical records
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Timepoint [1]
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At the end of recruitment period
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Eligibility
Key inclusion criteria
Adult patients (age 18 years or above) with moderate to severe TBI
Insertion of invasive neuromonitoring as per the treating clinical team
Potential to require osmotherapy for the management of intracranial hypertension.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Admission to the ICU is solely for the purposes of palliative care or confirmation of organ donation
Advanced care directive or previously stated wish not to be included in research activities
Bilateral fixed and dilated pupils and/or deemed to be non-survivable by treating clinical team
Pre-existing end stage renal failure, Child B or C liver disease,
Known G6PD deficiency or G6PD positivity on BinaxNOWTM G6PD Point-of-Care Qualitative Rapid Diagnostic Test (Lake Forest, Illinois, USA)
Plasma sodium > 150 mmol/L
Plasma sodium < 130 mmol/L
eGFR < 30 mL/min/1.73m2
Type 1 diabetes mellitus
History of ketoacidosis
Use of SGLT2 Inhibitors
Sickle cell disease
Confirmed or suspected pregnancy
History of oxalate renal stones
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/03/2025
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Actual
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Date of last participant enrolment
Anticipated
3/03/2026
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Actual
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Date of last data collection
Anticipated
27/03/2026
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Actual
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Sample size
Target
12
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Funding & Sponsors
Funding source category [1]
318309
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Other
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Name [1]
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GSK Award for Research Excellence
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Address [1]
318309
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Country [1]
318309
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
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Country
Australia
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Secondary sponsor category [1]
320695
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None
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Name [1]
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NA
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Address [1]
320695
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Country [1]
320695
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
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https://www.alfredhealth.org.au/research/ethics-research-governance
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
316944
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05/02/2025
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Approval date [1]
316944
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Ethics approval number [1]
316944
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Summary
Brief summary
The goal of COSMOS is to conduct an open label feasibility study of hypertonic sodium ascorbate for the management of intracranial hypertension in traumatic brain injury
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Andrew Udy
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Address
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Monash University, 553 St Kilda Road, Melbourne, VIC, 3004
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Country
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Australia
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Phone
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+61 438 755 568
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Camila Battistuzzo
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Address
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Monash University, 553 St Kilda Road, Melbourne, VIC, 3004
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Country
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Australia
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Phone
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+61 3 9903 0343
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mark Plummer
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Address
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Royal Adelaide Hospital, Port Road, Adelaide, SA 5000
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Country
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Australia
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Phone
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+61 0870740000
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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