Actively Recruiting
A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock
Led by Vivacelle Bio · Updated on 2025-04-04
46
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of VBI-S in raising blood pressure in patients suffering from septic shock with absolute or relative hypovolemia. Septic shock is a severe condition caused by infection leading to dangerously low blood pressure that does not improve with standard fluid treatments. This study is a Phase III, open-label, randomized controlled trial sponsored by Vivacelle Bio, aiming to address this urgent medical emergency. Participants will receive treatment with VBI-S, which consists of small particles of specific lipids called micelles and liposomes designed to treat hypotension. The study is randomized and controlled but open-label, meaning both participants and researchers know the treatment given. The Data Safety Monitoring Board will regularly review safety and study data to ensure participant well-being. During the study, participants will be closely monitored through various assessments including measurements of mean arterial pressure, doses of pressor drugs, organ function scores, oxygen levels, serum markers, and survival rates over a 12-month period. The primary outcome is the elevation in average mean arterial pressure. Assessments will help determine how VBI-S affects blood pressure and organ function while ensuring ongoing safety throughout the study duration.
CONDITIONS
Brief Title
A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female at least 18 years of age
- Evidence of bacterial infection shown by positive blood culture, known infection source, or procalcitonin level ≥ 2 ng/ml
- Mean blood pressure less than 65 mmHg that does not respond to available fluid treatments
- Sequential Organ Failure Assessment (SOFA) score of 5 or higher
- Sepsis diagnosis with at least two clinical signs such as high lactate, fever, hypothermia, elevated heart rate, rapid breathing, abnormal white blood cell count, elevated procalcitonin, arterial hypoxemia, increased creatinine, or abnormal clotting times
- Documented worsening organ function with SOFA score increase of 2 or more points after infection
- Receiving vasopressors to maintain target mean arterial pressure of 65 mmHg
You will not qualify if you...
- Patients with a ventricular assist device
- Acute coronary syndrome
- Pregnant individuals
- Acute bronchospasm
- Acute mesenteric ischemia
- Emergency major surgery
- Acute Hepatitis B or C diagnosis
- Blood disorders causing significant active bleeding or thrombocytopenia (platelet count below 50,000)
- White blood cell count below 1000/mm3
- Participation in another experimental or device study within 30 days before this study, except for COVID-19 drugs
- Known allergy to soybeans or eggs
- Hypervolemia as assessed by ultrasound within 12 hours before VBI-S infusion
- Expected to pass away within 12 hours
- Disorders affecting normal fat metabolism such as pathological hyperlipemia, lipid nephrosis, or pancreatitis with hyperlipidemia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of septic shock treatment as determined by the clinical team
Participants receive VBI-S to treat hypotension caused by septic shock.
Visits as needed during treatment to monitor blood pressure and organ function
Duration - Up to 12 months
Participants are monitored for safety and effectiveness outcomes over 12 months after treatment.
Regular follow-up visits over 12 months to assess blood pressure, organ function, and survival
Trial Site Locations
Total: 6 locations
1
Dignity Health Chandler Regional Medical Center
Chandler, Arizona, United States, 85224
Actively Recruiting
2
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
Actively Recruiting
3
University Health
Kansas City, Missouri, United States, 64108
Actively Recruiting
4
Bryan Medical Center
Lincoln, Nebraska, United States, 68506
Withdrawn
5
Novant Healthcare
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
6
Oregon Health & Science University (OHSU)
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
C
Cuthbert O Simpkins, MD, FACS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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