Dapagliflozin in Patients With Critical Illness: A Randomized Controlled Trial

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To assess the effects of dapagliflozin on a composite hierarchical endpoint in critically ill patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Israelita Albert Einstein
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

1. Patients admitted to an intensive care unit with expected duration of admission of at least 48 hours in the opinion of the attending physician AND

2. Patients with at least one new organ dysfunction:

1. Hypotension (mean arteria pressure below 65 mmHg or systolic blood pressure below 90 mmHg or use of vasopressors - norepinephrine, epinephrine, adrenaline, or vasopressin at any dose);

2. Signs of acute kidney injury (increase in serum creatinine above 0.3 mg/dL over previous measurement or decrease in urinary output - below 0.5 mL/kg/h - in the past six hours;

3. Need for new use of high-flow nasal catheter or noninvasive ventilation or invasive ventilation.

Exclusion Criteria:

1. Pregnancy or age below 18 years;

2. Patient or legal representative refusal;

3. Patients with chronic kidney disease on dialysis;

4. Planned intensive care unit admission after elective surgery;

5. Known allergy to dapagliflozin;

6. Previous use of dapagliflozin or other sodium-glucose transport protein 2 inhibitor;

7. Patients that cannot receive medications through oral or enteral route;

8. Patients with inclusion criteria number 2 for more than 24 hours.