A Phase 2 interventional study of Fresh Frozen Plasma (blood product) and MVI and lactated ringers in Sepsis, sponsored by Beth Israel Deaconess Medical Center. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Beth Israel Deaconess Medical Center · Phase 2, Interventional, and Treatment
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.
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's planned enrollment of 45 is below the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Two-unit initial FFP bolus, then one unit every 12 hours for 48 hours (total 5 units).
Biological: Fresh Frozen Plasma (blood product)
5 units FFP infused continuously at \~42 mL/hr over 48 hours.
Biological: Fresh Frozen Plasma (blood product)
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.
Drug: MVI and lactated ringers
Fresh Frozen Plasma
placebo
Change in Median Syndecan-1 Concentration
Change in Median Syndecan-1 Concentration
Time frame: baseline to study days 1,3,5
All-cause mortality to Day 28
All-cause mortality to Day 28
Time frame: 28 days
Organ failure-free days
Organ failure-free days to Day 28 (alive and without assisted ventilation, new RRT, or vasopressors).
Time frame: 28 days
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.
Time frame: change over days 1, 3, 5
No study locations are listed for this record.
Plan to share: Undecided — Plan Description: De-identified individual participant data (IPD) collected during the study will be made available. This will include the analyzable dataset underlying the primary and secondary outcomes, along with relevant clinical variables, laboratory data, and derived variables necessary to reproduce the reported findings. Data will be de-identified in accordance with applicable regulatory standards prior to sharing. Time Frame: Data will be available beginning 12 months after publication of the primary results and will remain available for at least 5 years thereafter. Access Criteria: Data will be made available to qualified investigators for secondary analyses upon reasonable request. Requests must include a brief proposal outlining the intended use of the data and will require execution of a data use agreement (DUA) to ensure appropriate use and protection of participant confidentiality. Data will be shared via a secure institutional or third-party data repository. Access is
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Beth Israel Deaconess Medical Center