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Safety and efficacy of sodium glucose cotransporter 2 inhibitors following cardiac arrest for hypoxic brain injury

Effect of SGLT2 inhibitors on cerebral injury and outcomes in comatose Out-Of-Hospital Cardiac Arrest survivors - a pilot study

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001183572
Acronym
PRIME-OOHCA
Enrollment
120
Registered
2024-09-27
Start date
2025-02-03
Completion date
2027-01-31
Last updated
2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A multi-center, double blind, placebo controlled, randomized pilot study is proposed to evaluate the effects of daily dapagliflozin given within 3 hours of arrest in comatose out-of-hospital cardiac arrest survivors for 30-days post cardiac arrest. The primary end point selected is the safety of dapagliflozin, measured as the total number of in-hospital adverse events. Adverse outcomes will be a composite of in-hospital mortality, ketoacidosis, need for renal replacement therapy, hypoglycaemia, and genitourinary infection. Secondary end points include post-arrest changes in biomarkers (neurofilament light chain, caspase 3, HIF-1a, VEGF, TNF-a, CRP) at 72 hours from baseline, CT-brain defined HIE changes and infarct size, 30-day mortality, and CPC (cerebral performance score) at time of discharge among survivors. This pilot study will aim to include 120 patients, half (n=60) assigned to the dapagliflozin group and half to the placebo. We expect this study will demonstrate the use of dapagliflozin in this population to be safe and effective at reducing biomarkers associated with hypoxic brain injury, allowing for further larger scale trials to explore the potential clinical benefit in reducing hypoxic brain injury in cardiac arrest.

Interventions

Once daily, nurse-led administration of dapagliflozin 10mg tablet nasograstrically/orally within 3 hours following comatose cardiac arrest, for 30 days.

Sponsors

Alfred Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026