NCT07160426

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at below P25 for phase_2 sepsis

Timeline
29mo left

Started Jul 2026

Typical duration for phase_2 sepsis

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

August 29, 2025

Last Update Submit

April 18, 2026

Conditions

Sepsis

Keywords

SepsisFresh Frozen PlasmaEndotheliumglycocalyx

Outcome Measures

Primary Outcomes (1)

  • Change in Median Syndecan-1 Concentration

    Change in Median Syndecan-1 Concentration

    baseline to study days 1,3,5

Secondary Outcomes (3)

  • All-cause mortality to Day 28

    28 days

  • Organ failure-free days

    28 days

  • Sequential Organ Failure Assessment (SOFA) Score

    change over days 1, 3, 5

Study Arms (3)

Experimental: FFP Bolus

EXPERIMENTAL

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

Biological: Fresh Frozen Plasma (blood product)

Experimental: FFP Continuous Infusion

EXPERIMENTAL

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

Biological: Fresh Frozen Plasma (blood product)

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.

Drug: MVI and lactated ringers

Interventions

Fresh Frozen Plasma (blood product)BIOLOGICAL

Fresh Frozen Plasma

Experimental: FFP BolusExperimental: FFP Continuous Infusion
MVI and lactated ringersDRUG

placebo

Placebo Comparator: Lactated Ringer's + Multivitamins

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Confirmed or suspected infection (pathogen detected or antimicrobial administered)
  • SOFA score ≥2
  • ICU patient or ED patient with anticipated ICU admission

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sepsis

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Nathan I. Shapiro, MD, MPH

CONTACT

617-754-2323nshapiro@bidmc.harvard.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Emergency Medicine

Study Record Dates

First Submitted

August 29, 2025

First Posted

September 8, 2025

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 22, 2026

Record last verified: 2026-04