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

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.

Inclusion criteria

• Age ≥18 years
• Confirmed or suspected infection (pathogen detected or antimicrobial administered)
• SOFA score ≥2
• ICU patient or ED patient with anticipated ICU admission

Exclusion criteria

• Unable to randomize within 24h of meeting inclusion criteria
• Current hospitalization >2 days
• Decision to withhold life-sustaining treatment (exception for DNR only)
• Moribund; not expected to survive 24h
• Life expectancy <28 days from non-sepsis condition
• Any condition where participation isn't in the patient's best interest or limits assessments
• Prisoner
• Pregnancy
• Concurrent interventional trial with overlapping treatments/outcomes
• Inability to obtain patient/LAR consent
• History of Transfusion Related Acute Lung Injury (TRALI) or Transfusion Associated Circulatory Overload (TACO)
• End Stage Renal Disease
• Chronic tracheostomy with ventilator use