Study of Protection And Repair of Endothelial-glycocalyx in Sepsis

NCT ID: NCT07160426

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-10-01

Brief Summary

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) FFP bolus regimen; (2) FFP continuous infusion; and (3) placebo (LR with multivitamins, administered as bolus or 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 (SOFA ≥2) within ICU or ED settings.

Conditions

Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental: FFP Bolus

Two-unit initial FFP bolus, then one unit every 12 hours for 48 hours (total 5 units).

Group Type: EXPERIMENTAL

Fresh Frozen Plasma (blood product)

Intervention Type: BIOLOGICAL

Fresh Frozen Plasma

Experimental: FFP Continuous Infusion

5 units FFP infused continuously at \~42 mL/hr over 48 hours.

Group Type: EXPERIMENTAL

Fresh Frozen Plasma (blood product)

Intervention Type: BIOLOGICAL

Fresh Frozen Plasma

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.

Group Type: PLACEBO_COMPARATOR

MVI and lactated ringers

Intervention Type: DRUG

placebo

Interventions

Fresh Frozen Plasma (blood product)

Fresh Frozen Plasma

Intervention Type: BIOLOGICAL

MVI and lactated ringers

placebo

Intervention Type: DRUG

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado Health

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Nathan Shapiro

Professor of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Nathan I. Shapiro, MD, MPH

Role: CONTACT

nshapiro@bidmc.harvard.edu

617-754-2323

Other Identifiers

SPARES Pilot

Identifier Type: -

Identifier Source: org_study_id