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

NCT ID: NCT06072430

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-06
• Study Completion Date: 2025-12-31

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.

Conditions

Septic Shock; Sepsis; Hypovolemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VBI-S

Treatment with VBI-S

Group Type: EXPERIMENTAL

VBI-S

Intervention Type: DRUG

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

Interventions

VBI-S

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

Intervention Type: DRUG

Eligibility 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vivacelle Bio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cuthbert O Simpkins, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Vivacelle Bio

Locations

Dignity Health Chandler Regional Medical Center

Chandler, Arizona, United States

Site Status: RECRUITING

Memorial Health University Medical Center

Savannah, Georgia, United States

Site Status: RECRUITING

University Health

Kansas City, Missouri, United States

Site Status: RECRUITING

Bryan Medical Center

Lincoln, Nebraska, United States

Site Status: WITHDRAWN

Novant Healthcare

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Oregon Health & Science University (OHSU)

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cuthbert O Simpkins, MD, FACS

Role: CONTACT

cuthbert@vivacellebio.com

3187711294

Facility Contacts

Kristopher Roach, MD

Role: primary

Domenick Roma, MD

Role: primary

Michael Moncure, MD

Role: primary

Daniel Feinstein, MD

Role: primary

Akram Khan, MD

Role: primary

Other Identifiers

VBI-S-02

Identifier Type: -

Identifier Source: org_study_id