Study of Protection And Repair of Endothelial-glycocalyx in Sepsis (SPARES)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fresh Frozen Plasma (blood product), MVI and lactated ringers.
- Who it may be relevant to
- Registry conditions: Sepsis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Study of Protection And Repair of Endothelial-glycocalyx in Sepsis (SPARES)
Overview
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.
Detailed description
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.
Interventions
- Biological Fresh Frozen Plasma (blood product)
Fresh Frozen Plasma - Drug MVI and lactated ringers
placebo
Primary outcome measures
- Change in Median Syndecan-1 Concentration [Time frame: baseline to study days 1,3,5]
Secondary outcome measures (3)
- All-cause mortality to Day 28 [Time frame: 28 days]
- Organ failure-free days [Time frame: 28 days]
- Sequential Organ Failure Assessment (SOFA) Score [Time frame: change over days 1, 3, 5]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07160426 · SPARES Pilot