A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in… (NCT06072430) | Clinical Trial Compass
RecruitingPhase 3
A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)
United States46 participantsStarted 2024-08-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. Sepsis diagnosis: The presence of infection which can be proven or suspected by 2 or more of the following criteria:
✓. 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.
✓. Receiving vasopressors to maintain the target MAP of 65 mmHg.
✕. Hematologic or coagulation disorders including thrombocytopenia (platelet count \<50,000) and associated with hemodynamically significant active bleeding that causes a decrease in blood pressure.