Dapagliflozin in Patients With Critical Illness

Sponsor
Hospital Israelita Albert Einstein
Study ID
NCT05558098
Phase
PHASE3
Status
Completed

Conditions

  • Critical Illness
  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10mg Tab — DRUG
    Dapagliflozin 10 mg once per day for 14 days or until intensive care unit discharge or death
  • Standard of Care — OTHER
    Current standard of care for management of critically ill patients

Study Details

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

Key Dates

Start date
Nov 1, 2022
Status verified
Oct 2023
Primary completion
Oct 20, 2023
Completion
Oct 20, 2023

Study Design

Enrollment
507 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care
    Current standard of care for 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

Primary Outcome Measure

Win Ratio [ Time Frame: 28 days ]

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