Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT06748105
Eligibility Criteria:
Inclusion Criteria:
* Patients over 18 years old admitted to the emergency department with a need for hospitalization, under the care of the Internal Medicine and Hemato-Oncology departments, from May to November 2024.
* Patients with a clinical indication for high-dose glucocorticoid use (prednisone bioequivalence \>30mg/day).
Exclusion Criteria:
* Current treatment with SGLT2 inhibitors, sulfonylureas, or insulin infusion pumps.
* Contraindications for SGLT2 inhibitors: chronic kidney disease (KDIGO stage IV), acute kidney injury or disease, type 1 diabetes, suspected severe acute infection, requirement for surgery, severe urinary tract infection.
* Previous use of high-dose glucocorticoids within the last 30 days. Indication for aggressive fluid resuscitation, use of vasopressors, use of mineralocorticoids, requirement for invasive mechanical ventilation, or classified as critically ill.
* Uncontrolled hyperglycemia (\>140mg/dL despite proper treatment) or suspected euglycemic diabetic ketoacidosis.
* Use of glucocorticoids in the past 28 days with doses higher than medium doses (prednisone equivalence \>10mg and \<30mg/day).
* Inability to take dapagliflozin orally.
* Pregnancy, postpartum, or lactation.
* Patients with incomplete follow-up or inadequate adherence to the intervention protocol, or those who experience adverse effects related to dapagliflozin use.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06748105
Study Brief:
Protocol Section:
NCT06748105