Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001183572p
Ethics application status
Not yet submitted
Date submitted
2/09/2024
Date registered
27/09/2024
Date last updated
27/09/2024
Date data sharing statement initially provided
27/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and efficacy of sodium glucose cotransporter 2 inhibitors following cardiac arrest for hypoxic brain injury
Scientific title
Effect of SGLT2 inhibitors on cerebral injury and outcomes in comatose Out-Of-Hospital Cardiac Arrest survivors - a pilot study
Secondary ID [1] 312872 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PRIME-OOHCA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiac arrest 335021 0
hypoxic brain injury 335022 0
Condition category
Condition code
Neurological 331532 331532 0 0
Other neurological disorders
Cardiovascular 331592 331592 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once daily, nurse-led administration of dapagliflozin 10mg tablet nasograstrically/orally within 3 hours following comatose cardiac arrest, for 30 days.
Intervention code [1] 329412 0
Treatment: Drugs
Comparator / control treatment
Once daily, nurse-led administration of placebo microcrystalline cellulose tablet nasogastrically/orally within 3 hours following comatose cardiac arrest, for 30 days.
Control group
Placebo

Outcomes
Primary outcome [1] 339277 0
Composite of adverse events, including mortality, ketoacidosis, renal failure requiring renal replacement therapy, genitourinary infection and hypoglycaemia.
Timepoint [1] 339277 0
Assessed daily for 30 days following comatose cardiac arrest.
Secondary outcome [1] 439344 0
Biomarkers of hypoxic brain injury (neurofilament light chain)
Timepoint [1] 439344 0
Baseline and 72 hours following cardiac arrest
Secondary outcome [2] 439534 0
Biomarkers of ischaemia-reperfusion injury (C reactive protein)
Timepoint [2] 439534 0
At baseline and at 72 hours following cardiac arrest
Secondary outcome [3] 439537 0
Extent of hypoxic brain injury
Timepoint [3] 439537 0
Within 30 days following comatose cardiac arrest
Secondary outcome [4] 439538 0
Cognitive function
Timepoint [4] 439538 0
On discharge from hospital
Secondary outcome [5] 439947 0
30-day mortality
Timepoint [5] 439947 0
30 days following cardiac arrest
Secondary outcome [6] 440156 0
Biomarkers of ischaemia-reperfusion injury (interleukin 6)
Timepoint [6] 440156 0
Baseline and at 72 hours post cardiac arrest
Secondary outcome [7] 440157 0
Biomarkers of ischaemia-reperfusion injury (hypoxic inducible factor 1 alpha)
Timepoint [7] 440157 0
At baseline and at 72 hours post cardiac arrest
Secondary outcome [8] 440158 0
Biomarkers of ischaemia-reperfusion injury (nuclear factor-KB)
Timepoint [8] 440158 0
At baseline and at 72 hours post cardiac arrest
Secondary outcome [9] 440159 0
Biomarkers of ischaemia-reperfusion injury (transforming growth factor beta)
Timepoint [9] 440159 0
At baseline and at 72 hours post cardiac arrest
Secondary outcome [10] 440160 0
Biomarkers of ischaemia-reperfusion injury (tumour necrosis factor alpha)
Timepoint [10] 440160 0
At baseline and at 72 hours post cardiac arrest
Secondary outcome [11] 440161 0
Biomarkers of ischaemia-reperfusion injury (vascular endothelial growth factor)
Timepoint [11] 440161 0
At baseline and at 72 hours post cardiac arrest
Secondary outcome [12] 440162 0
Biomarkers of ischaemia-reperfusion injury (caspase 3)
Timepoint [12] 440162 0
At baseline and at 72 hours post cardiac arrest

Eligibility
Key inclusion criteria
• Consecutive adults aged 18 years or older presenting with comatose out-of-hospital cardiac arrest suspected to be caused by acute coronary syndrome (ACS) as defined as either ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI).
• Total downtime prior to return of spontaneous circulation of less than 30 minutes.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with a history of type 1 diabetes
• Patients already treated with an SGLT2 inhibitor
• Patients with an eGFR <25 ml/min/1.73m2 or receiving dialysis

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
31/01/2027
Actual
Date of last data collection
Anticipated
2/03/2027
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317315 0
Self funded/Unfunded
Name [1] 317315 0
Country [1] 317315 0
Primary sponsor type
Hospital
Name
Alfred Health
Address
Country
Australia
Secondary sponsor category [1] 319597 0
None
Name [1] 319597 0
Address [1] 319597 0
Country [1] 319597 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316047 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316047 0
Ethics committee country [1] 316047 0
Australia
Date submitted for ethics approval [1] 316047 0
24/10/2024
Approval date [1] 316047 0
Ethics approval number [1] 316047 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136606 0
Prof William Chan
Address 136606 0
The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria, 3004
Country 136606 0
Australia
Phone 136606 0
+61 435612868
Fax 136606 0
Email 136606 0
[email protected]
Contact person for public queries
Name 136607 0
Brendan Backhouse
Address 136607 0
The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria, 3004
Country 136607 0
Australia
Phone 136607 0
+61 421189381
Fax 136607 0
Email 136607 0
[email protected]
Contact person for scientific queries
Name 136608 0
Brendan Backhouse
Address 136608 0
The Alfred Hospital, 55 Commercial Road, Melbourne, Victoria, 3004
Country 136608 0
Australia
Phone 136608 0
+61 421189381
Fax 136608 0
Email 136608 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.