NCT06072430 · Vivacelle Bio
A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)
(VBI-S-02)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
VBI-S
VBI-S is made of small particles of specific lipids called micelles and liposomes for the treatment of hypotension.
Primary outcome measures
Elevation in Average Mean Arterial Pressure
Time frame: 12 months
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Chandler, Arizona
- Savannah, Georgia
- Kansas City, Missouri
- Lincoln, Nebraska
- Winston-Salem, North Carolina
- Portland, Oregon
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 4, 2025 · Source of record for eligibility and locations