SepsisPhase 2SPARESNCT07160426
Study of Protection And Repair of Endothelial-glycocalyx in Sepsis (SPARES)
A Phase 2 study testing Fresh Frozen Plasma (blood product) and MVI and lactated ringers in people with Sepsis, run by Beth Israel Deaconess Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Fresh Frozen Plasma (blood product) and MVI and lactated ringers
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Confirmed or suspected infection (pathogen detected or antimicrobial administered)
- SOFA score ≥2
- ICU patient or ED patient with anticipated ICU admission
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pilot Study of Protection And Repair of Endothelial-glycocalyx in Sepsis (SPARES)
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.
Read the detailed description
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.
- Conditions
- Sepsis
- Being tested
- Fresh Frozen Plasma (blood product), MVI and lactated ringers
- Keywords
- Sepsis, Fresh Frozen Plasma, Endothelium, glycocalyx
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh Frozen Plasma (blood product)Biological
Fresh Frozen Plasma
MVI and lactated ringersDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental: FFP Bolus | Experimental | Two-unit initial FFP bolus, then one unit every 12 hours for 48 hours (total 5 units). Receives: Biological: Fresh Frozen Plasma (blood product) |
| Experimental: FFP Continuous Infusion | Experimental | 5 units FFP infused continuously at ~42 mL/hr over 48 hours. Receives: 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. Receives: Drug: MVI and lactated ringers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Median Syndecan-1 Concentration
Change in Median Syndecan-1 Concentration
Measured: baseline to study days 1,3,5
Secondary outcomes (3)
All-cause mortality to Day 28
All-cause mortality to Day 28
Measured: 28 days
Organ failure-free days
Organ failure-free days to Day 28 (alive and without assisted ventilation, new RRT, or vasopressors).
Measured: 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.
Measured: change over days 1, 3, 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado Health
- Responsible party
- Principal investigator, Nathan Shapiro, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160426
- Sponsor's protocol ID
- SPARES Pilot
- Acronym
- SPARES
- Status last verified
- Apr 2026
- First submitted
- 29 Aug 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Protection And Repair of Endothelial-glycocalyx in Sepsis (SPARES)
- ClinicalTrials.gov ID
- NCT07160426
- Acronym / sponsor ID
- SPARES / SPARES Pilot
- Conditions
- Sepsis
- Keywords
- Sepsis, Fresh Frozen Plasma, Endothelium, glycocalyx
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- University of Colorado Health
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: FFP Bolus | Experimental | Biological: Fresh Frozen Plasma (blood product)Two-unit initial FFP bolus, then one unit every 12 hours for 48 hours (total 5 units). |
| Experimental: FFP Continuous Infusion | Experimental | Biological: Fresh Frozen Plasma (blood product)5 units FFP infused continuously at ~42 mL/hr over 48 hours. |
| Placebo Comparator: Lactated Ringer's + Multivitamins | Placebo comparator | Drug: MVI and lactated ringersPlacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Confirmed or suspected infection (pathogen detected or antimicrobial administered)
- SOFA score ≥2
- ICU patient or ED patient with anticipated ICU admission
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresh Frozen Plasma (blood product)Fresh Frozen Plasma | Biological | Experimental: FFP Bolus, Experimental: FFP Continuous Infusion |
| MVI and lactated ringersplacebo | Drug | Placebo Comparator: Lactated Ringer's + Multivitamins |
Primary outcome
Change in Median Syndecan-1 Concentration
Time frame: baseline to study days 1,3,5
Change in Median Syndecan-1 Concentration
3 secondary outcomes
All-cause mortality to Day 28
Time frame: 28 days
Organ failure-free days
Time frame: 28 days
Sequential Organ Failure Assessment (SOFA) Score
Time frame: change over days 1, 3, 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fresh Frozen Plasma (blood product) and MVI and lactated ringers in people with Sepsis, run by Beth Israel Deaconess Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathan I. Shapiro, MD, MPH (617-754-2323, nshapiro@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Median Syndecan-1 Concentration (time frame: baseline to study days 1,3,5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.