Health TrialsbyHealthPanel

Study of Protection And Repair of Endothelial-glycocalyx in Sepsis (SPARES)

ConditionSepsis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeth Israel Deaconess Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Confirmed or suspected infection (pathogen detected or antimicrobial administered)

SOFA score ≥2

ICU patient or ED patient with anticipated ICU admission

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fresh Frozen Plasma (blood product)

    Biological/Vaccine

    Fresh Frozen Plasma

  • MVI and lactated ringers

    Drug

    placebo

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Experimental: FFP BolusExperimental treatment 1 intervention
Group B: Experimental: FFP Continuous InfusionExperimental treatment 1 intervention
Group C: Placebo Comparator: Lactated Ringer's + MultivitaminsPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Median Syndecan-1 Concentration

Change in Median Syndecan-1 Concentration

Time frame
baseline to study days 1,3,5

Secondary outcomes

1

All-cause mortality to Day 28

All-cause mortality to Day 28

Time frame
28 days
2

Organ failure-free days

Organ failure-free days to Day 28 (alive and without assisted ventilation, new RRT, or vasopressors).

Time frame
28 days
3

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beth Israel Deaconess Medical Center

Lead sponsor

University of Colorado Health

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: