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

  1. Study completion expected

  2. Primary completion expected

  3. Started

  4. Last registry update

  5. Registered