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Clinical Trial NCT07488689 (GLIFLOSHOCK) for Septic Shock is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Assessing the Efficacy of Dapagliflozin as a Vasculoprotective Treatment in Septic Shock Patients With Microcirculatory Dysfunction (GLIFLOSHOCK) Phase 3 568 Randomized Double-Blind Observational Novel Treatment

Not yet recruiting
Clinical Trial NCT07488689 (GLIFLOSHOCK) is designed to study Treatment for Septic Shock. This Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on 1 July 2026 until the study accrues 568 participants. Led by University Hospital, Strasbourg, France, this study is expected to complete by 1 July 2030. The latest data from ClinicalTrials.gov was last updated on 27 March 2026.
Brief Summary
Microcirculatory dysfunction is a key driver of organ failure and mortality in septic shock, characterized by endothelial injury and impaired vasoregulation. Despite its strong prognostic value, it remains unaddressed by current therapies. SGLT-2 inhibitors (SGLT-2i) have shown promising vasculoprotective, anti-inflammatory, and glucose-lowering effects that may help restore endothelial function, reduce vascular leak...Show More
Official Title

Assessing the Efficacy of Dapagliflozin as a Vasculoprotective Treatment in Septic Shock Patients With Microcirculatory Dysfunction

Conditions
Septic Shock
Other Study IDs
  • GLIFLOSHOCK
  • RC25_0052
  • 2025-524820-23-00 (EU Study (CTIS) Number)
NCT ID Number
NCT07488689
Start Date (Actual)
2026-07
Last Update Posted
2026-03-27
Completion Date (Estimated)
2030-07
Enrollment (Estimated)
568
Study Type
Interventional
PHASE
Phase 3
Status
Not yet recruiting
Keywords
microcirculatory dysfunction
septic shock
dapagliflozin
SGLT-2i
gliflozins
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalDapagliflozin
administration of once-daily oral dapagliflozin 10 mg for 7 days
Dapaglifozin
Oral Dapaglifozin 10mg once-daily administration, for 7 days
Placebo ComparatorPlacebo
administration of once-daily oral placebo for 7 days
Placebo
Oral Placebo once-daily administration, for 7 days
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Composite endpoint including all-cause mortality, weaning of vasopressor, and initiation of renal replacement therapy.
These outcomes will be observed up to 28 days post-randomization, with events censored at the point of hospital discharge
weaning of vasopressor: day 5, all-cause mortality: day 28, initiation of renal replacement therapy: day 28.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Patient aged ≥ 18 years
  2. Hospitalized in ICU for septic shock according to Sepsis-3 definition (PMID: 26903338). Septic shock should be the primary reason for admission.
  3. Septic shock diagnosed for less than 12 hours prior to randomization
  4. Skin mottling (mottling score ≥ 2) according to Ait-Oufella and/or prolonged capillary refill time > 3 seconds
  5. Patient benefiting from social health insurance (or having a close relative who is a beneficiary)
  6. Patient or legal representative having signed an informed consent to participate in the study. In case immediate consent is not possible, an emergency procedure will be applied in accordance with current regulations

  1. Patient in whom oral administration is not possible at the initial stage (e.g., emergency digestive surgery, acute mesenteric ischemia, etc.).
  2. Patient treated with SGLT2 inhibitor before ICU admission
  3. Hypoglycemia < 0.5 g/L (2.75 mmol/L)
  4. End-stage kidney disease undergoing maintenance dialysis
  5. Medical history of type 1 diabetes (gliflozins are not authorized for treatment of this type of diabetes)
  6. Medical history of diabetic ketoacidosis
  7. Ongoing Fournier's gangrene
  8. Current treatment with lithium
  9. Cirrhose child C
  10. Do not resuscitate order at inclusion in the study
  11. Concomitant participation in another interventional therapeutic trial
  12. Patient deprived of liberty or under legal protection (guardianship, conservatorship, or legal protection)
  13. Pregnancy or breastfeeding
  14. Contraindications to dapagliflozin
University Hospital, Strasbourg, France logoUniversity Hospital, Strasbourg, France
Study Central Contact
Contact: Sarah HUSTACHE, 03 88 11 54 15, [email protected]
Contact: Hamid MERDJI, MD, PhD, [email protected]
1 Study Locations in 1 Countries
Hôpital Civil, Service de médecine intensive et réanimation, Hôpitaux Universitaires de Strasbourg, Strasbourg, France
Hamid MERDJI, MD, PhD, Contact, 03 69 55 11 23, [email protected]