NCT07160426

Study of Protection And Repair of Endothelial-glycocalyx in Sepsis

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Multicenter, blinded, placebo-controlled randomized pilot trial comparing: (1) FFP bolus regimen; (2) FFP continuous infusion; and (3) placebo (LR with multivitamins, administered as bolus or 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 (SOFA ≥2) within ICU or ED settings.

Conditions

• Sepsis

Interventions

Type	Name	Description
BIOLOGICAL	Fresh Frozen Plasma (blood product)	Fresh Frozen Plasma
DRUG	MVI and lactated ringers	placebo

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-06-01
• Completion: 2027-10-01
• First posted: 2025-09-08
• Last updated: 2025-09-08