A Randomized Controlled Trial of Empagliflozin versus Placebo on Clinical, Biochemical and Outcome Markers in Critically ill ICU Patients with Acute Heart Failure

We designed the present study to address the critical evidence gap by evaluating the clinical, biochemical and outcome effects of early empagliflozin initiation in patients with acute heart failure in the intensive care unit.

Patient will be then included in the study after fulfilling the inclusion and exclusion criteria. Patient will be enrolled within 24 of admission in ICU after block randomization.

Patients will be randomized in a 1:1 ratio to the empagliflozin and placebo arms using a computer-generated randomization sequence. The sequence will be created locally using permuted blocks of four to ensure balanced allocation while maintaining allocation concealment. The randomization list will be prepared by a study investigator not involved in patient enrolment or treatment. Allocations will be placed in sequentially numbered, opaque, sealed envelopes, which will be opened only after the participant is deemed eligible and consented to trial. Treating clinicians and outcome assessors will have no access to the randomization sequence.

Patient will receive the standard management for acute heart failure along with empagliflozin 10mg once daily per oral and placebo (vitamin C tablet) as per intensivist and cardiologist decision.

Strict fluid balance charting will be done during entire ICU stay. Dyspnea VAS will be assessed within 24 hour of admission and at day 3. Duration and modality of respiratory support will be noted. Need for vasopressor support and dialysis will be assessed. Intervention will be stopped in case of adverse effects, if any as per treating clinician decision. Total dose of diuretics received in ICU will be noted. NT proBNP levels will be done at admission and day 3. Patient will be followed for 30 days post discharge from hospital. Duration of treatment will be decided as per treating physician post discharge.