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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified March 2025 by Vivacelle Bio
Sponsor
Vivacelle Bio
Information Provided by (Responsible Party)
Vivacelle Bio
Clinicaltrials.gov Identifier
NCT06072430
Other Study ID Numbers:
VBI-S-02
First Submitted
September 13, 2023
First Posted
October 9, 2023
Last Update Posted
April 3, 2025
Last Verified
March 2025

ClinicalTrials.gov processed this data on April 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
Septic ShockSepsisHypovolemia
Drug: VBI-S

Study Design

Study TypeInterventional
Actual Enrollment46 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock
Study Start DateAugust 5, 2024
Actual Primary Completion DateNovember 30, 2025
Actual Study Completion DateNovember 30, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
VBI-S
Treatment with VBI-S
Drug: VBI-S
VBI-S is made of small particles of specific lipids called micelles and liposomes for the treatment of hypotension.

Outcome Measures

Primary Outcome Measures
  1. 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
Secondary Outcome Measures
  1. 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.
  2. 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.
  3. 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).
  4. Arterial Oxygen Saturation
    Change in arterial oxygen saturation.
  5. Partial Pressure of Oxygen
    Change in partial pressure of oxygen.
  6. Serum Procalcitonin
    Change in serum procalcitonin
  7. Serum Creatinine
    Change serum creatinine
  8. Post-treatment Survival
    Change in post-treatment survival

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsVivacelle Bio
Locations
Dignity Health Chandler Regional Medical Center | Chandler Arizona, United States, 85224Memorial Health University Medical Center | Savannah Georgia, United States, 31404University Health | Kansas City Missouri, United States, 64108Bryan Medical Center | Lincoln Nebraska, United States, 68506Novant Healthcare | Winston-Salem North Carolina, United States, 27103Oregon Health & Science University (OHSU) | Portland Oregon, United States, 97239
Investigators
Principal Investigator: Cuthbert O Simpkins, MD, FACS, Vivacelle Bio