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

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT07160426
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fresh Frozen Plasma (blood product) — BIOLOGICAL
    Fresh Frozen Plasma
  • MVI and lactated ringers — DRUG
    placebo

Study Details

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.

Key Dates

First listed
Sep 8, 2025
Start date
Jul 1, 2026
Status verified
Apr 2026
Primary completion
Jun 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: FFP Bolus
    Two-unit initial FFP bolus, then one unit every 12 hours for 48 hours (total 5 units).
  • Experimental: Experimental: FFP Continuous Infusion
    5 units FFP infused continuously at \~42 mL/hr over 48 hours.
  • Placebo Comparator: Placebo Comparator: Lactated Ringer's + Multivitamins
    Placebo given as either (a) 500 mL LR bolus, then 250 mL q12h for 48h (total 1,250 mL), or (b) 500 mL over 12h, repeated to total 2,000 mL over 48h; prepared by pharmacy to match plasma appearance.

Primary Outcome Measure

Change in Median Syndecan-1 Concentration [ Time Frame: baseline to study days 1,3,5 ]

Central Contacts

Related Studies