Hypovolemia, Sepsis, Septic Shock
Conditions
Brief summary
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.
Detailed description
PURPOSE OF THE STUDY 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. STUDY TREATMENT Sepsis is a serious condition resulting from the presence of harmful microorganisms in the blood or other tissues and the body's response to their presence, leading to the malfunctioning of various organs. When hypotension due to sepsis cannot be reversed with the infusion of fluids the patient is in a state of septic shock. Septic shock is therefore an acute medical emergency and delayed therapy can lead to organ injury. VBI-S is intended to raise blood pressure in patients with septic shock. Randomization and blinding: This is a randomized, controlled, open-label study and blinding is not applicable to this study. Data Safety Monitoring Board: A Data Safety Monitoring Board (DSMB) will review the study data.
Interventions
DRUGVBI-S
VBI-S is made of small particles of specific lipids called micelles and liposomes for the treatment of hypotension.
Sponsors
Vivacelle Bio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Elevation in Average Mean Arterial Pressure | 12 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose of Pressor Drugs | 12 months | The number of patients in whom the dose of pressor drugs could be decreased after infusion of VBI-S to maintain a mean arterial pressure of 60-65 mmHg. |
| Sequential Organ Failure Assessment (SOFA) Score | 12 months | Change in Sequential Organ Failure Assessment (SOFA) Score on a scale of 0 to 24. A higher score indicates a worse outcome. |
| Ratio of Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen | 12 months | Change in ratio of partial pressure of oxygen in arterial blood/Fraction of inspired oxygen (P/F ratio). |
| Arterial Oxygen Saturation | 12 months | Change in arterial oxygen saturation. |
| Serum Procalcitonin | 12 months | Change in serum procalcitonin |
| Serum Creatinine | 12 months | Change serum creatinine |
| Post-treatment Survival | 12 months | Change in post-treatment survival |
| Partial Pressure of Oxygen | 12 months | Change in partial pressure of oxygen. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Drug Reactions | 12 months | The number and proportion (%) of patients with treatment-emergent adverse drug reactions. |
Countries
United States
Contacts
Primary ContactCuthbert O Simpkins, MD, FACS
Outcome results
None listed