Phase 3Not yet recruiting
Assessing the Efficacy of Dapagliflozin as a Vasculoprotective Treatment in Septic Shock Patients With Microcirculatory Dysfunction (GLIFLOSHOCK)
- Sponsor
- University Hospital, Strasbourg, France (Academic or other)
- Enrolment
- 568 planned
- Conditions
- Septic Shock
- Interventions
- Dapaglifozin; Placebo
- Ages
- adults, older adults
- Registry
- NCT07488689, CTIS2025-524820-23-00
Full record on ClinicalTrials.gov
From the registry
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 leakage, and manage stress-induced hyperglycemia-factors central to septic shock pathophysiology. Preclinical and clinical observational studies suggest potential benefits, but clinical research in this specific context is lacking. This trial aims to evaluate the efficacy and safety of SGLT-2i in septic shock patients with clinical signs of microcirculatory failure, addressing a critical unmet medical need. Septic shock management relies on rapid infection control, hemodynamic stabilization with fluids and vasopressors, and supportive care, with corticosteroids used in select cases. However, this standardized approach faces major limitations due to patient heterogeneity,…
Primary outcomes
- Composite endpoint including all-cause mortality, weaning of vasopressor, and initiation of renal replacement therapy.
History
Study completion expected
Primary completion expected
Started
Last registry update
Registered