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

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vivacelle Bio

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 or an elevated procalcitonin.

3. Patient has a mean blood pressure < 65 mmHg that is unresponsive to fluids currently available on the market.

4. Patient is on two or more pressor drugs at the following minimal doses: Levophed =20 mcg/minute, epinephrine 10 mcg/minute, dopamine 20 mcg/kg/minute, phenylephrine 180mcg/minute, vasopressin 4 units/hour, at full dose required to maintain a mean blood pressure of 65 mmHg or Patient is on Levophed or its equivalent at 55 mcg/min with conversion factors for other vasopressors to Levophed being 5.6 x Vasopressin ( in units/hour), 0.5 x dopamine( in mcg/kg/minute) epinephrine ( in mcg/minute) 0.1 x phenylephrine ( in mcg/minute) at full dose to maintain a mean blood pressure of 65 mmHg. (Predicted mortality >80%)

5. Sequential Organ Failure Assessment (SOFA) score >=15 (Predicted mortality >80%)

6. Systolic blood pressure < 90 mm Hg (or a drop of > 40 mm Hg from baseline)

7. Sepsis diagnosis

Exclusion Criteria:

1. Patients with a ventricular assist device

2. Acute coronary syndrome

3. Pregnant

4. Bronchospasm

5. Mesenteric ischemia

6. Emergency surgery

7. History of liver disease (Hepatitis B and C), chronic hepatic failure and /or cirrhosis

8. Liver failure with a Model for End-Stage Liver Disease (MELD) score ≥ 19

9. Clinically significant hematologic or coagulation disorders including thrombocytopenia (platelet count <50,000)

10. Absolute neutrophil count of < 1000 mm3

11. Current participation or participation in another experimental or device study within the last 30 days before the start of this study

12. Patients with a known allergy to soybeans or eggs