DEFENDER: Dapagliflozin in Patients With Critical Illness
Study Details
Study Description
Brief Summary
To assess the effects of dapagliflozin on a composite hierarchical endpoint in critically ill patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Standard of Care Current standard of care for critically ill patients. |
Other: Standard of Care
Current standard of care for management of critically ill patients
|
| Active Comparator: Standard of care plus dapagliflozin Current standard of care for critically ill patients plus open-label dapagliflozin 10 mg per day for 14 days or until ICU discharge |
Drug: Dapagliflozin 10mg Tab
Dapagliflozin 10 mg once per day for 14 days or until intensive care unit discharge or death
|
Outcome Measures
Primary Outcome Measures
- Win Ratio [28 days]
Hierarchical endpoint of hospital mortality, use of kidney replacement therapy and intensive care unit length-of-stay
Secondary Outcome Measures
- Hospital Mortality [28 days]
Death within index hospitalization
- Use of kidney replacement therapy [28 days]
Use of kidney replacement therapy during hospital stay
- Intensive Care Unit Free Days [28 days]
Number of days patient was alive and not in the intensive care unit within index hospitalization
- Hospital Free Days [28 days]
Number of days patient was alive and not in the hospital
- Vasopressor Free Days [28 days]
Number of days patient was alive and not using vasopressors at any dose within index hospitalization
- Mechanical Ventilation Free Days [28 days]
Number of days patient was alive and not using mechanical ventilation within index hospitalization
- Kidney Replacement Therapy Free Days [28 days]
Number of days patient was alive and not using kidney replacement therapy within index hospitalization
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
-
Patients with at least one new organ dysfunction:
-
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);
-
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;
-
Need for new use of high-flow nasal catheter or noninvasive ventilation or invasive ventilation.
Exclusion Criteria:
-
Pregnancy or age below 18 years;
-
Patient or legal representative refusal;
-
Patients with chronic kidney disease on dialysis;
-
Planned intensive care unit admission after elective surgery;
-
Known allergy to dapagliflozin;
-
Previous use of dapagliflozin or other sodium-glucose transport protein 2 inhibitor;
-
Patients that cannot receive medications through oral or enteral route;
-
Patients with inclusion criteria number 2 for more than 24 hours.
-
Patients with type 1 diabetes
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital de Amor | Barretos | São Paulo | Brazil | |
| 2 | Hospital Santa Paula | São Paulo | Brazil |
Sponsors and Collaborators
- Hospital Israelita Albert Einstein
Investigators
- Study Chair: Otavio Berwanger, PhD, Academic Research Organization
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DEFENDER