Pilot Study of Protection And Repair of Endothelial-glycocalyx in Sepsis (SPARES)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Change in Median Syndecan-1 Concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Confirmed or suspected infection (pathogen detected or antimicrobial administered)
- •SOFA score ≥2
- •ICU patient or ED patient with anticipated ICU admission
排除标准
- •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
- •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
研究组 & 干预措施
Experimental: FFP Bolus
Two-unit initial FFP bolus, then one unit every 12 hours for 48 hours (total 5 units).
干预措施: Fresh Frozen Plasma (blood product) (Biological)
Experimental: FFP Continuous Infusion
5 units FFP infused continuously at ~42 mL/hr over 48 hours.
干预措施: Fresh Frozen Plasma (blood product) (Biological)
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.
干预措施: MVI and lactated ringers (Drug)
结局指标
主要结局
Change in Median Syndecan-1 Concentration
时间窗: baseline to study days 1,3,5
Change in Median Syndecan-1 Concentration
Syndecan-1
时间窗: baseline to study days 1,3,5
Syndecan-1 measurement
次要结局
- Sequential Organ Failure Assessment (SOFA) Score(change over days 1, 3, 5)
- All-cause mortality to Day 28(28 days)
- Organ failure-free days(28 days)
- SOFA Score(change over days 1, 3, 5)
研究者
Nathan Shapiro
Professor of Emergency Medicine
Beth Israel Deaconess Medical Center