Study of Protection And Repair of Endothelial-glycocalyx in Sepsis (SPARES)

Overview

Sepsis damages the blood vessel lining and its protective "glycocalyx," contributing to organ failure and death. This pilot, randomized, blinded study will test whether giving fresh frozen plasma (FFP)-either as intermittent boluses or as a continuous infusion-protects or repairs the glycocalyx compared with look-alike placebo fluid (lactated Ringer's with multivitamins), and whether this leads to better clinical outcomes. We will measure blood and urine biomarkers of glycocalyx injury and track organ support needs, ICU/hospital-free days, and survival through 28-90 days.

Multicenter, blinded, placebo-controlled randomized pilot trial comparing: (1) Fresh Frozen Plasma bolus regimen; (2) FFP continuous infusion; and (3) placebo (Lactated Ringers with multivitamins, administered as bolus or semi-continuous to maintain blinding). Primary biologic readout is change in syndecan-1 (glycocalyx degradation) with additional endothelial activation and inflammation markers; key clinical endpoints include mortality and organ failure-free days. Target enrollment is 45 adults with sepsis (Sequential Organ Failure Assessment (SOFA) ≥2) within Intensive Care Unit or Emergency Department settings.

Conditions

Interventions