drugset / Trial / NCT07160426
Study of Protection And Repair of Endothelial-glycocalyx in Sepsis (SPARES)
Phase 2
Not yet recruiting
45 enrolled
Beth Israel Deaconess Medical Center
University of Colorado Health · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fresh Frozen Plasma | Protein / enzyme biologic | 1 unknown | — |
| Subject | Fresh Frozen Plasma | Protein / enzyme biologic | 5 unknown | — |