VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients

VBI-S-02

This study is being conducted to evaluate the safety and effectiveness of VBI-S in elevating the blood pressure of septic shock patients with absolute or relative hypovolemia.

2023-10-01

2024-08-01

2024-10-01

Not yet recruiting

Early phase I

34

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 and ≤ 11 with the maximum SOFA score of 24. 5. Failure of standard therapy defined as no decrease in the SOFA score for 48 hours or a SOFA score \> 11 on admission to the ICU. 6. 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 * INR \> 1.5 or aPTT \> 60 seconds 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 with the last 30 days before the start of this study. Patient may be included if on other drugs for COVID-19 11. Patients with a known allergy to soybeans or eggs 12. Patient is hypervolemic as assessed by ultrasound 13. Patient expected to expire within 12 hours

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 34, 'type': 'ESTIMATED'}}

2023-10-26