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

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Sepsis

In brief

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 facts

Study ID

NCT07160426

Run by

Beth Israel Deaconess Medical Center

People needed

45

Starts

2026-07-01

Expected to finish

2028-12-01

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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