Evaluating VBI-S for treating low blood pressure in septic shock patients

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

This study is testing if a new treatment called VBI-S can help raise blood pressure in patients with septic shock when regular fluids aren't working.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vivacelle Bio (industry)
• Locations: 6 sites (Chandler, Arizona and 5 other locations)
• Trial ID: NCT06072430 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of VBI-S in increasing blood pressure in patients experiencing septic shock due to hypovolemia. The study involves a randomized, open-label design where participants will receive VBI-S if they meet specific criteria related to sepsis and hypotension. The trial will monitor patient responses and safety through a Data Safety Monitoring Board. The goal is to provide a potential new treatment option for patients whose blood pressure does not improve with standard fluid therapies.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with septic shock and unresponsive hypotension despite fluid resuscitation.

Not a fit: Patients who do not have septic shock or whose blood pressure responds adequately to existing fluid treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve blood pressure management in septic shock patients, potentially reducing organ injury and improving survival rates.

How similar studies have performed: Other studies have explored treatments for septic shock, but the specific use of VBI-S represents a novel approach in this context.

Eligibility criteria

Inclusion Criteria:

1. Male or female at least 18 years of age.
2. Evidence of bacterial infection demonstrated by positive blood culture and/or a known source of infection and/or an elevated procalcitonin of ≥ 2 ng/ml.
3. Patient has a mean blood pressure \< 65 mmHg that is unresponsive to fluids currently available on the market.
4. Sequential Organ Failure Assessment (SOFA) score ≥ 5
5. Sepsis diagnosis: The presence of infection which can be proven or suspected by 2 or more of the following criteria:

   * 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.

Exclusion Criteria:

1. Patients with a ventricular assist device
2. Acute coronary syndrome
3. Pregnant
4. Acute bronchospasm
5. Acute Mesenteric ischemia
6. Emergency major surgery
7. Diagnosis of acute Hepatitis B or C.
8. Hematologic or coagulation disorders including thrombocytopenia (platelet count \<50,000) and associated with hemodynamically significant active bleeding that causes a decrease in blood pressure.
9. White blood cell count of \< 1000 mm3
10. Current participation or participation in another experimental or device study within the last 30 days before the start of this study. Patient may be included if on other drugs are for COVID-19.
11. Patients with a known allergy to soybeans or eggs
12. Patient is hypervolemic with assessment by physician or physician extender ultrasound 12 hours before infusion of VBI-S if hypervolemia is suspected.
13. Patient expected to expire within 12 hours.
14. Patients with disturbances in normal fat metabolism such as pathologic hyperlipemia, lipid nephrosis, or acute pancreatitis with hyperlipidemia.

Where this trial is running

Chandler, Arizona and 5 other locations

• Dignity Health Chandler Regional Medical Center — Chandler, Arizona, United States (RECRUITING)
• Memorial Health University Medical Center — Savannah, Georgia, United States (RECRUITING)
• University Health — Kansas City, Missouri, United States (RECRUITING)
• Bryan Medical Center — Lincoln, Nebraska, United States (WITHDRAWN)
• Novant Healthcare — Winston-Salem, North Carolina, United States (RECRUITING)
• Oregon Health & Science University (OHSU) — Portland, Oregon, United States (RECRUITING)

Study contacts

• Principal investigator: Cuthbert O Simpkins, MD, FACS — Vivacelle Bio
• Study coordinator: Cuthbert O Simpkins, MD, FACS

Conditions: Septic Shock, Sepsis, Hypovolemia