A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)
- Conditions
- Septic ShockSepsisHypovolemia
- Registration Number
- NCT06072430
- Lead Sponsor
- Vivacelle Bio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Male or female at least 18 years of age.<br><br> 2. Evidence of bacterial infection demonstrated by positive blood culture and/or a<br> known source of infection and/or an elevated procalcitonin of = 2 ng/ml.<br><br> 3. Patient has a mean blood pressure < 65 mmHg that is unresponsive to fluids currently<br> available on the market.<br><br> 4. Sequential Organ Failure Assessment (SOFA) score = 5<br><br> 5. Sepsis diagnosis: The presence of infection which can be proven or suspected by 2 or<br> more of the following criteria:<br><br> - Lactate > 2 mmol/L<br><br> - Fever > 38.3°C, or 101°F<br><br> - Hypothermia < 36°C core temperature (<96.8°F)<br><br> - Heart rate > 90<br><br> - Tachypnea (respiratory rate = 20/min)<br><br> - White blood cell count >12,000 or less than 4,000, or with >10% bands<br> (immature forms)<br><br> - Elevated procalcitonin in serum (= 2ng/ml)<br><br> - Arterial hypoxemia (PaO2/FiO2 < 300)<br><br> - Creatinine increase > 0.5 mg/dL since hospital admission<br><br> - INR > 1.5 or aPTT > 60 seconds<br><br> 6. Documented dysregulated host response to an infection as indicated by an increase in<br> SOFA score by = 2 points after an infection per the SEPSIS 3 guideline.<br><br> 7. Receiving vasopressors to maintain the target MAP of 65 mmHg.<br><br>Exclusion Criteria:<br><br> 1. Patients with a ventricular assist device<br><br> 2. Acute coronary syndrome<br><br> 3. Pregnant<br><br> 4. Acute bronchospasm<br><br> 5. Acute Mesenteric ischemia<br><br> 6. Emergency major surgery<br><br> 7. Diagnosis of acute Hepatitis B or C.<br><br> 8. Hematologic or coagulation disorders including thrombocytopenia (platelet count<br> <50,000) and associated with hemodynamically significant active bleeding that causes<br> a decrease in blood pressure.<br><br> 9. White blood cell count of < 1000 mm3<br><br> 10. Current participation or participation in another experimental or device study<br> within the last 30 days before the start of this study. Patient may be included if<br> on other drugs are for COVID-19.<br><br> 11. Patients with a known allergy to soybeans or eggs<br><br> 12. Patient is hypervolemic with assessment by physician or physician extender<br> ultrasound 12 hours before infusion of VBI-S if hypervolemia is suspected.<br><br> 13. Patient expected to expire within 12 hours.<br><br> 14. Patients with disturbances in normal fat metabolism such as pathologic hyperlipemia,<br> lipid nephrosis, or acute pancreatitis with hyperlipidemia.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Elevation in Average Mean Arterial Pressure
- Secondary Outcome Measures
Name Time Method Dose of Pressor Drugs;Sequential Organ Failure Assessment (SOFA) Score;Ratio of Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen;Arterial Oxygen Saturation;Partial Pressure of Oxygen;Serum Procalcitonin;Serum Creatinine;Post-treatment Survival