[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605277":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":35,"studyPopulation":23,"armGroups":36,"interventions":53,"overallOfficials":23,"centralContacts":64,"locations":23,"responsibleParty":70,"collaborators":74,"id":77,"slug":23,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":23,"enrollmentInfo":86,"targetDuration":23,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":98,"whyStopped":23,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":23},{"fullName":5,"class":6},"Beth Israel Deaconess Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":12,"otherOutcomes":23},[9],{"measure":10,"description":10,"timeFrame":11},"Change in Median Syndecan-1 Concentration","baseline to study days 1,3,5",[13,16,19],{"measure":14,"description":14,"timeFrame":15},"All-cause mortality to Day 28","28 days",{"measure":17,"description":18,"timeFrame":15},"Organ failure-free days","Organ failure-free days to Day 28 (alive and without assisted ventilation, new RRT, or vasopressors).",{"measure":20,"description":21,"timeFrame":22},"Sequential Organ Failure Assessment (SOFA) Score","Sequential Organ Failure Assessment (SOFA) Score is an established score for quantifying organ dysfunction in sepsis with a range of 0-24 points, with higher numbers indicating greater organ dysfunction and higher severity.","change over days 1, 3, 5",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":29,"maskingDescription":23,"whoMasked":30},"QUADRUPLE",[31,32,33,34],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","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.",[37,43,47],{"label":38,"type":39,"description":40,"interventionNames":41},"Experimental: FFP Bolus","EXPERIMENTAL","Two-unit initial FFP bolus, then one unit every 12 hours for 48 hours (total 5 units).",[42],"Biological: Fresh Frozen Plasma (blood product)",{"label":44,"type":39,"description":45,"interventionNames":46},"Experimental: FFP Continuous Infusion","5 units FFP infused continuously at \\~42 mL\u002Fhr over 48 hours.",[42],{"label":48,"type":49,"description":50,"interventionNames":51},"Placebo Comparator: Lactated Ringer's + Multivitamins","PLACEBO_COMPARATOR","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.",[52],"Drug: MVI and lactated ringers",[54,59],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":23},"BIOLOGICAL","Fresh Frozen Plasma (blood product)","Fresh Frozen Plasma",[38,44],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":23},"DRUG","MVI and lactated ringers","placebo",[48],[65],{"name":66,"role":67,"phone":68,"phoneExt":23,"email":69},"Nathan I. Shapiro, MD, MPH","CONTACT","617-754-2323","nshapiro@bidmc.harvard.edu",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Nathan Shapiro","Professor of Emergency Medicine",[75],{"name":76,"class":6},"University of Colorado Health","100605277",false,"NCT07160426","Study of Protection And Repair of Endothelial-glycocalyx in Sepsis (SPARES)","Pilot Study of Protection And Repair of Endothelial-glycocalyx in Sepsis (SPARES)","SPARES","Inclusion Criteria:\n\n* Age ≥18 years\n* Confirmed or suspected infection (pathogen detected or antimicrobial administered)\n* SOFA score ≥2\n* ICU patient or ED patient with anticipated ICU admission\n\nExclusion Criteria:\n\n* Unable to randomize within 24h of meeting inclusion criteria\n* Current hospitalization \\>2 days\n* Decision to withhold life-sustaining treatment (exception for DNR only)\n* Moribund; not expected to survive 24h\n* Life expectancy \\\u003C28 days from non-sepsis condition\n* Any condition where participation isn't in the patient's best interest or limits assessments\n* Prisoner\n* Pregnancy\n* Concurrent interventional trial with overlapping treatments\u002Foutcomes\n* Inability to obtain patient\u002FLAR consent\n* History of Transfusion Related Acute Lung Injury (TRALI) or Transfusion Associated Circulatory Overload (TACO)\n* End Stage Renal Disease\n* Chronic tracheostomy with ventilator use","ALL","18 Years",{"count":87,"type":88},45,"ESTIMATED","INTERVENTIONAL",[91],"PHASE2","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\u002Fhospital-free days, and survival through 28-90 days.",[94],"Sepsis",[94,57,96,97],"Endothelium","glycocalyx","NOT_YET_RECRUITING","2026-04-18",{"date":101,"type":102},"2026-04-22","ACTUAL",{"date":104,"type":88},"2026-07-01",{"date":106,"type":88},"2028-12-01",{"name":5,"class":6}]