drugset / Trial / NCT07160426

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

NCT07160426

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-07-01
Primary completion
2028-06-01
Completion
2028-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Fresh Frozen Plasma Protein / enzyme biologic 1 unknown
Subject Fresh Frozen Plasma Protein / enzyme biologic 5 unknown