VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients
- Registration Number
- NCT04257136
- Lead Sponsor
- Vivacelle Bio
- Brief 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 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
- Patients with a ventricular assist device
- Acute coronary syndrome
- Pregnant
- Bronchospasm
- Mesenteric ischemia
- Emergency surgery
- Acute liver disease (Hepatitis B and C as examples)
- Liver failure with a Model for End-Stage Liver Disease (MELD) score ≥ 19
- Hematologic or coagulation disorders including thrombocytopenia (platelet count <50,000) and associated with hemodynamically significant active bleeding.
- Absolute neutrophil count of < 1000 mm3
- Current participation or participation in another experimental or device study within the last 30 days before the start of this study. Patient may be included if on other drugs for COVID-19 and or septic shock
- Patients with a known allergy to soybeans or eggs
- Patient is hypervolemic as assessed by CVP, ultrasound, Swan Ganz catheter, Flo-Trac, esophageal doppler, bioimpedance, ECHO, Partial carbon dioxide rebreathing (NICO), lithium dilution (LIDCO) or other method published in a peer reviewed journal
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment VBI-S Treatment with VBI-S
- Primary Outcome Measures
Name Time Method 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. 10 Months 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.
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (8)
UMD Shock Trauma
🇺🇸Baltimore, Maryland, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Truman Medical Center
🇺🇸Kansas City, Missouri, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Einstine Medical Center
🇺🇸East Norriton, Pennsylvania, United States
Dignity Health
🇺🇸Chandler, Arizona, United States
Adventist Health Care
🇺🇸Silver Spring, Maryland, United States