Dapagliflozin in Patients With Critical Illness
DEFENDER
1 other identifier
interventional
507
1 country
23
Brief Summary
To assess the effects of dapagliflozin on a composite hierarchical endpoint in critically ill patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2022
Shorter than P25 for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2022
CompletedFirst Posted
Study publicly available on registry
September 28, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2023
CompletedOctober 31, 2023
October 1, 2023
12 months
September 23, 2022
October 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Win Ratio
Hierarchical endpoint of hospital mortality, use of kidney replacement therapy and intensive care unit length-of-stay
28 days
Secondary Outcomes (7)
Hospital Mortality
28 days
Use of kidney replacement therapy
28 days
Intensive Care Unit Free Days
28 days
Hospital Free Days
28 days
Vasopressor Free Days
28 days
- +2 more secondary outcomes
Study Arms (2)
Standard of Care
ACTIVE COMPARATORCurrent standard of care for critically ill patients.
Standard of care plus dapagliflozin
ACTIVE COMPARATORCurrent standard of care for critically ill patients plus open-label dapagliflozin 10 mg per day for 14 days or until ICU discharge
Interventions
Dapagliflozin 10 mg once per day for 14 days or until intensive care unit discharge or death
Current standard of care for management of critically ill patients
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 type 1 diabetes or previous ketoacidosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Hospital de Emergência Dr. Daniel Houly
Arapiraca, Alagoas, Brazil
Hospital e Maternidade São José
Colatina, Espírito Santo, Brazil
Instituto de Ensino e Pesquisa do Hospital da Bahia
Salvador, Estado de Bahia, Brazil
Hospital Brasilia
Brasília, Federal District, Brazil
Hospital Municipal de Aparecida de Goiânia
Aparecida de Goiânia, Goiás, Brazil
Hospital Santa Lucia
Poços de Caldas, Minas Gerais, Brazil
Hospital das Nações
Curitiba, Paraná, Brazil
Hospital Ecoville - Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Oliveira
Vacaria, Rio Grande do Sul, Brazil
Hospital Baia Sul
Florianópolis, Santa Catarina, Brazil
Centro de Pesquisa Clínica do Coração
Aracaju, Sergipe, 49055-530, Brazil
Hospital de Amor de Barretos
Barretos, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Hospital Nove de Julho
São Paulo, São Paulo, Brazil
Santa Casa de Barretos
Barretos, Brazil
Santa Casa de Curitiba
Curitiba, Brazil
Hospital de Amor de Jales
Jales, Brazil
Unimed Joinville
Joinville, Brazil
Hospital São Lucas de Copacabana
Rio de Janeiro, Brazil
Hospital Municipal Vila Santa Catarina
São Paulo, Brazil
Hospital M´Boi Mirim
São Paulo, Brazil
Hospital Santa Paula
São Paulo, Brazil
Related Publications (3)
Tavares CAM, Azevedo LCP, Guimaraes PO, Rea-Neto A, David-Joao PG, Campos NS, Amendola CP, Kozesinski-Nakatani AC, Filiponi TC, Almeida GMB, Bergo RR, Lobo SM, Tognon AP, Tavares MS, Silveira FS, Dracoulakis MDA, Biondi RS, Monfardini F, Nieri J, Madrini V Jr, Serpa-Neto A, Bacal F, Lemos PA, Berwanger O, Ezekowitz JA, Zampieri FG; DEFENDER Investigators. Dapagliflozin in Acute Cardiovascular Conditions: Insights From the DEFENDER Trial. JACC Adv. 2025 Dec 19;5(1):102459. doi: 10.1016/j.jacadv.2025.102459. Online ahead of print.
PMID: 41421016DERIVEDTavares CAM, Azevedo LCP, Rea-Neto A, Campos NS, Amendola CP, Kozesinski-Nakatani AC, David-Joao PG, Lobo SM, Filiponi TC, Almeida GMB, Bergo RR, Guimaraes-Junior MRR, Figueiredo RC, Castro JR, Schuler CJ, Westphal GA, Carioca ACR, Monfradini F, Nieri J, Neves FMO, Paulo JA, Albuquerque CSN, Silva MCR, Kosiborod MN, Pereira AJ, Damiani LP, Correa TD, Serpa-Neto A, Berwanger O, Zampieri FG; DEFENDER Investigators. Dapagliflozin for Critically Ill Patients With Acute Organ Dysfunction: The DEFENDER Randomized Clinical Trial. JAMA. 2024 Aug 6;332(5):401-411. doi: 10.1001/jama.2024.10510.
PMID: 38873723DERIVEDTavares CAM, Azevedo LCP, Rea-Neto A, Campos NS, Amendola CP, Bergo RR, Kozesinski-Nakatani AC, David-Joao PG, Westphal GA, Guimaraes Junior MRR, Lobo SMA, Tavares MS, Dracoulakis MDA, Souza GM, Almeida GMB, Gebara OCE, Tomba PO, Albuquerque CSN, Silva MCR, Pereira AJ, Damiani LP, Correa TD, Serpa-Neto A, Berwanger O, Zampieri FG. Dapagliflozin in patients with critical illness: rationale and design of the DEFENDER study. Crit Care Sci. 2023 Dec 22;35(3):256-265. doi: 10.5935/2965-2774.20230129-en. eCollection 2023.
PMID: 38133155DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Otavio Berwanger, PhD
Academic Research Organization
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2022
First Posted
September 28, 2022
Study Start
November 1, 2022
Primary Completion
October 20, 2023
Study Completion
October 20, 2023
Last Updated
October 31, 2023
Record last verified: 2023-10