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New treatment option for Septic Shock
Official title A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)
ClinicalTrials.gov ID: NCT06072430
What this study is testing
What is VBI-S?
VBI-S is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for septic shock.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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:
You likely can't join if
- Patients with a ventricular assist device
- Acute coronary syndrome
- Pregnant
- Acute bronchospasm
- Acute Mesenteric ischemia
- Emergency major surgery
See the full eligibility 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:
- Lactate \> 2 mmol/L
- Fever \> 38.3°C, or 101°F
- Hypothermia \< 36°C core temperature (\<96.8°F)
- Heart rate \> 90
- Tachypnea (respiratory rate ≥ 20/min)
- White blood cell count \>12,000 or less than 4,000, or with \>10% "bands" (immature forms)
- Elevated procalcitonin in serum (≥ 2ng/ml)
- Arterial hypoxemia (PaO2/FiO2 \< 300)
- Creatinine increase \> 0.5 mg/dL since hospital admission
- INR \> 1.5 or aPTT \> 60 seconds
- 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.
- Patients with a ventricular assist device
- Acute coronary syndrome
- Pregnant
- Acute bronchospasm
- Acute Mesenteric ischemia
- Emergency major surgery
- Diagnosis of acute Hepatitis B or C.
- Hematologic or coagulation disorders including thrombocytopenia (platelet count \<50,000) and associated with hemodynamically significant active bleeding that causes a decrease in blood pressure.
- White blood cell 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 are for COVID-19.
- Patients with a known allergy to soybeans or eggs
- Patient is hypervolemic with assessment by physician or physician extender ultrasound 12 hours before infusion of VBI-S if hypervolemia is suspected.
- Patient expected to expire within 12 hours.
- Patients with disturbances in normal fat metabolism such as pathologic hyperlipemia, lipid nephrosis, or acute pancreatitis with hyperlipidemia.
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Savannah, Georgia, United States
- Kansas City, Missouri, United States
- Lincoln, Nebraska, United States
- Winston-Salem, North Carolina, United States
- Portland, Oregon, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Savannah, Georgia, United States; Kansas City, Missouri, United States; Lincoln, Nebraska, United States; Winston-Salem, North Carolina, United States; Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.