A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock
Vivacelle Bio
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 de…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 te…
Interventions
- DrugVBI-S
VBI-S is made of small particles of specific lipids called micelles and liposomes for the treatment of hypotension.
Locations (6)
- Dignity Health Chandler Regional Medical CenterChandler, Arizona
- Memorial Health University Medical CenterSavannah, Georgia
- University HealthKansas City, Missouri
- Bryan Medical CenterLincoln, Nebraska
- Novant HealthcareWinston-Salem, North Carolina
- Oregon Health & Science University (OHSU)Portland, Oregon