Study of Protection And Repair of Endothelial-glycocalyx in Sepsis (SPARES)
ConditionSepsis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeth Israel Deaconess Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥18 years
Confirmed or suspected infection (pathogen detected or antimicrobial administered)
SOFA score ≥2
ICU patient or ED patient with anticipated ICU admission
Disqualifiers
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
Trial design
Treatments tested in this trial
- Fresh Frozen Plasma (blood product)
- MVI and lactated ringers
Treatment groups
45 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Beth Israel Deaconess Medical Center
Lead sponsor
University of Colorado Health
Collaborator
Source ClinicalTrials.gov