Clinical trial NCT04257136: VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients
Official title: VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Septic Shock
Sepsis
Hypovolemia
Lead sponsor: Vivacelle Bio
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 20
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 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

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 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
   * Mottled skin
   * Decreased capillary refill of nail beds or skin
   * Fever \> 38.3˚C, or 101˚F
   * Hypothermia \< 36˚C core temperature (\<96.8˚F)
   * Heart rate \> 90
   * Tachypnea
   * Change in mental status
   * Significant edema or positive fluid balance (\>20 mL/kg over 24 hours)
   * Hyperglycemia (\>140 mg/dL) in someone without diabetes
   * White blood cell count \>12,000 or less than 4,000, or with \>10% "bands" (immature
   * forms)
   * Elevated C-reactive protein in serum (according to your lab's cutoffs)
   * Elevated procalcitonin in serum (≥ 2 ng/ml)
   * Arterial hypoxemia (PaO2/FiO2 \< 300)
   * Acute drop in urine output (\<0.5 ml/kg/hr for at least 2 hours despite fluid resuscitation, or about 30 ml/hour for a 70 kg person)
   * Creatinine increase \> 0.5 mg/dL
   * INR \> 1.5 or aPTT \> 60 seconds
   * Absent bowel sounds (ileus)
   * High bilirubin (total bilirubin \> 4 mg/dL

Exclusion Criteria:

1. Patients with a ventricular assist device
2. Acute coronary syndrome
3. Pregnant
4. Bronchospasm
5. Mesenteric ischemia
6. Emergency surgery
7. Acute liver disease (Hepatitis B and C as examples)
8. Liver failure with a Model for End-Stage Liver Disease (MELD) score ≥ 19
9. Hematologic or coagulation disorders including thrombocytopenia (platelet count \<50,000) and associated with hemodynamically significant active bleeding.
10. Absolute neutrophil count of \< 1000 mm3
11. 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
12. Patients with a known allergy to soybeans or eggs
13. 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

Primary outcomes:
measure: 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.
timeFrame: 10 Months
Secondary outcomes:
measure: 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
timeFrame: 10 Months
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Dignity Health
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Baltimore
country: United States
facility: UMD Shock Trauma
state: Maryland
city: Silver Spring
country: United States
facility: Adventist Health Care
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Kansas City
country: United States
facility: Truman Medical Center
state: Missouri
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: East Norriton
country: United States
facility: Einstine Medical Center
state: Pennsylvania
Study officials:
affiliation: Vivacelle Bio
name: Cuthbert Simpkins, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: