None listed
Conditions
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
Sponsors
Study design
Eligibility
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