A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)

Sepsis Clinical Trial

— VBI-S-02  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06072430
• Other study ID #: VBI-S-02
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Vivacelle Bio
• Contact: Cuthbert O Simpkins, MD, FACS
• Phone: 3187711294
• Email: cuthbert[@]vivacellebio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: July 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypovolemia
• Sepsis
• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• VBI-S
VBI-S is made of small particles of specific lipids called micelles and liposomes for the treatment of hypotension.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vivacelle Bio

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Drug Reactions	The number and proportion (%) of patients with treatment-emergent adverse drug reactions.	12 months
Primary	Elevation in Average Mean Arterial Pressure	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	12 months
Secondary	Dose of Pressor Drugs	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.	12 months
Secondary	Sequential Organ Failure Assessment (SOFA) Score	Change in Sequential Organ Failure Assessment (SOFA) Score on a scale of 0 to 24. A higher score indicates a worse outcome.	12 months
Secondary	Ratio of Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen	Change in ratio of partial pressure of oxygen in arterial blood/Fraction of inspired oxygen (P/F ratio).	12 months
Secondary	Arterial Oxygen Saturation	Change in arterial oxygen saturation.	12 months
Secondary	Partial Pressure of Oxygen	Change in partial pressure of oxygen.	12 months
Secondary	Serum Procalcitonin	Change in serum procalcitonin	12 months
Secondary	Serum Creatinine	Change serum creatinine	12 months
Secondary	Post-treatment Survival	Change in post-treatment survival	12 months