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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
VBI-S is made of small particles of specific lipids called micelles and liposomes for the treatment of hypotension.
Dignity Health Chandler Regional Medical Center
Chandler, Arizona, United States
RECRUITINGMemorial Health University Medical Center
Savannah, Georgia, United States
RECRUITINGUniversity Health
Kansas City, Missouri, United States
Elevation in Average Mean Arterial Pressure
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
Time frame: 12 months
Dose of Pressor Drugs
The number of patients in whom the dose of pressor drugs could be decreased after infusion of VBI-S to maintain a mean arterial pressure of 60-65 mmHg.
Time frame: 12 months
Sequential Organ Failure Assessment (SOFA) Score
Change in Sequential Organ Failure Assessment (SOFA) Score on a scale of 0 to 24. A higher score indicates a worse outcome.
Time frame: 12 months
Ratio of Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen
Change in ratio of partial pressure of oxygen in arterial blood/Fraction of inspired oxygen (P/F ratio).
Time frame: 12 months
Arterial Oxygen Saturation
Change in arterial oxygen saturation.
Time frame: 12 months
Partial Pressure of Oxygen
Change in partial pressure of oxygen.
Time frame: 12 months
Serum Procalcitonin
Change in serum procalcitonin
Time frame: 12 months
Serum Creatinine
Change serum creatinine
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bryan Medical Center
Lincoln, Nebraska, United States
WITHDRAWNNovant Healthcare
Winston-Salem, North Carolina, United States
RECRUITINGOregon Health & Science University (OHSU)
Portland, Oregon, United States
RECRUITINGTime frame: 12 months
Post-treatment Survival
Change in post-treatment survival
Time frame: 12 months