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 an open label study, randomization and blinding are not applicable to this study. All patients entering this study will be treated with VBI-S. Data Safety Monitoring Board: A Data Safety Monitoring Board (DSMB) will review the study data. Analysis Populations: \* Safety Analysis Set (SAF): all patients who have received any amount of VBI-S. \* Intent to treat (ITT) population: all patients who have received any amount of VBI-S
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
VBI-S is made of small particles of specific lipid called micelles and liposomes for the treatment of hypotension.
Dignity Health
Chandler, Arizona, United States
University of Arizona
Tucson, Arizona, United States
UMD Shock Trauma
Baltimore, Maryland, United States
Adventist Health Care
Silver Spring, Maryland, United States
The primary endpoint of this study is the proportion of patients in whom mean blood pressure increased by at least 10 mmHg with a mean blood pressure target of 60 - 65 mmHg.
The primary endpoint of this study is the proportion of patients in whom mean blood pressure increased by at least 10 mmHg with a mean blood pressure target of 60 - 65 mmHg.
Time frame: 10 Months
The secondary endpoint of this study is the proportion 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
The secondary endpoint of this study is the proportion 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: 10 Months
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Henry Ford Health System
Detroit, Michigan, United States
Truman Medical Center
Kansas City, Missouri, United States
Mount Sinai Hospital
New York, New York, United States
Einstine Medical Center
East Norriton, Pennsylvania, United States