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VBI-S for Septic Shock with Low Blood Pressure

This study is testing a new treatment called VBI-S for patients experiencing septic shock (a severe infection causing very low blood pressure) and hypovolemia (low blood volume). VBI-S is made of tiny particles designed to help raise blood pressure. Researchers want to see if VBI-S is safe and effective in bringing blood pressure up for these patients. You might be able to join if you are at least 18 years old, have a confirmed bacterial infection, and your blood pressure is below 65 mmHg even after receiving fluids. The study aims to enroll 46 participants and will measure how much VBI-S raises your average blood pressure over 12 months.

Study design
This is an open-label, randomized, controlled study, meaning some participants will receive VBI-S and others will receive standard care, and everyone will know which treatment they are getting. The study plans to include 46 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 12 months, suggesting participants will be followed for at least this long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06072430

A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Vivacelle Bio
~46 participants
Updated 2025-04-04 on ClinicalTrials.gov
What's tested:VBI-S

At a glance

Recruiting sites
5 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Elevation in Average Mean Arterial Pressure
Measured over 12 months

Conditions

Septic Shock
Sepsis
Hypovolemia

Explore related trials

HypovolemiaSepticemiaSeptic Shock

Where it's being run

6 sites across 6 states
Arizona1
Georgia1
Missouri1
Nebraska1
North Carolina1
Oregon1

Study leadership

  • Cuthbert O Simpkins, MD, FACS · PRINCIPAL_INVESTIGATOR · Vivacelle Bio

Who to contact

Cuthbert O Simpkins, MD, FACS
[email protected]
3187711294
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Lactate \> 2 mmol/L
Fever \> 38.3°C, or 101°F
Hypothermia \< 36°C core temperature (\<96.8°F)
Heart rate \> 90
Tachypnea (respiratory rate ≥ 20/min)
White blood cell count \>12,000 or less than 4,000, or with \>10% "bands" (immature forms)
Elevated procalcitonin in serum (≥ 2ng/ml)
Arterial hypoxemia (PaO2/FiO2 \< 300)
Creatinine increase \> 0.5 mg/dL since hospital admission
INR \> 1.5 or aPTT \> 60 seconds 6. Documented dysregulated host response to an infection as indicated by an increase in SOFA score by ≥ 2 points after an infection per the SEPSIS 3 guideline. 7. Receiving vasopressors to maintain the target MAP of 65 mmHg.

What this trial measures

  • Elevation in Average Mean Arterial Pressure12 months

    The primary endpoint is defined as an elevation in average mean arterial pressure by at least 10 mmHg from baseline within 3 hours of initiation of study treatment on Day 1