Clinical trial NCT06072430: A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)
Official title: A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Septic Shock
Sepsis
Hypovolemia
Lead sponsor: Vivacelle Bio
Sponsor class: INDUSTRY
First posted: 2023-10-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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: Inclusion Criteria:

1. Male or female at least 18 years of age.
2. 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.
3. Patient has a mean blood pressure \< 65 mmHg that is unresponsive to fluids currently available on the market.
4. Sequential Organ Failure Assessment (SOFA) score ≥ 5
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
6. 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.
7. Receiving vasopressors to maintain the target MAP of 65 mmHg.

Exclusion Criteria:

1. Patients with a ventricular assist device
2. Acute coronary syndrome
3. Pregnant
4. Acute bronchospasm
5. Acute Mesenteric ischemia
6. Emergency major surgery
7. Diagnosis of acute Hepatitis B or C.
8. Hematologic or coagulation disorders including thrombocytopenia (platelet count \<50,000) and associated with hemodynamically significant active bleeding that causes a decrease in blood pressure.
9. White blood cell count of \< 1000 mm3
10. 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.
11. Patients with a known allergy to soybeans or eggs
12. Patient is hypervolemic with assessment by physician or physician extender ultrasound 12 hours before infusion of VBI-S if hypervolemia is suspected.
13. Patient expected to expire within 12 hours.
14. Patients with disturbances in normal fat metabolism such as pathologic hyperlipemia, lipid nephrosis, or acute pancreatitis with hyperlipidemia.

Primary outcomes:
measure: Elevation in Average Mean Arterial Pressure
timeFrame: 12 months
Secondary outcomes:
measure: Dose of Pressor Drugs
timeFrame: 12 months
measure: Sequential Organ Failure Assessment (SOFA) Score
timeFrame: 12 months
measure: Ratio of Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen
timeFrame: 12 months
measure: Arterial Oxygen Saturation
timeFrame: 12 months
measure: Partial Pressure of Oxygen
timeFrame: 12 months
measure: Serum Procalcitonin
timeFrame: 12 months
measure: Serum Creatinine
timeFrame: 12 months
measure: Post-treatment Survival
timeFrame: 12 months
Other outcomes:
measure: Adverse Drug Reactions
timeFrame: 12 months
Locations:
city: Chandler
country: United States
facility: Dignity Health Chandler Regional Medical Center
state: Arizona
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Kansas City
country: United States
facility: University Health
state: Missouri
city: Lincoln
country: United States
facility: Bryan Medical Center
state: Nebraska
city: Winston-Salem
country: United States
facility: Novant Healthcare
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University (OHSU)
state: Oregon
Study officials:
affiliation: Vivacelle Bio
name: Cuthbert O Simpkins, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: