A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)
Start Date
8/6/2024
Completion Date
12/1/2025
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.
Detailed 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 delayed therapy can lead to organ injury. VBI-S is intended to raise blood pressure in patients with septic shock. Randomization and blinding: This is a randomized, controlled, open-label study and blinding is not applicable to this study. Data Safety Monitoring Board: A Data Safety Monitoring Board (DSMB) will review the study data.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
VBI-S
Conditions
Locations
Dignity Health Chandler Regional Medical Center
Chandler, Arizona 85224
United States
Memorial Health University Medical Center
Savannah, Georgia 31404
United States
University Health
Kansas City, Missouri 64108
United States
Bryan Medical Center
Lincoln, Nebraska 68506
United States
Novant Healthcare
Winston-Salem, North Carolina 27103
United States
Oregon Health & Science University (OHSU)
Portland, Oregon 97239
United States