A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorVivacelle Bio
About this trial
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.
Eligibility criteria
Qualifiers
Male or female at least 18 years of age.
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.
Patient has a mean blood pressure < 65 mmHg that is unresponsive to fluids currently available on the market.
Sequential Organ Failure Assessment (SOFA) score ≥ 5
Disqualifiers
Patients with a ventricular assist device
Acute coronary syndrome
Pregnant
Acute bronchospasm
Trial design
Treatments tested in this trial
- VBI-S
Treatment groups
46 Participants
are divided into 1 treatment groupLocations
6Arizona
Dignity Health Chandler Regional Medical Center85224, Chandler United States
Georgia
Memorial Health University Medical Center31404, Savannah United States
Missouri
University Health64108, Kansas City United States
Nebraska
Bryan Medical Center68506, Lincoln United States
Sponsors and collaborators
Vivacelle Bio
Lead sponsor
Source ClinicalTrials.gov