VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients

Status unconfirmed · Phase 2

Conditions studied: Septic Shock, Sepsis, Hypovolemia

In brief

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.

Key facts

Study ID

NCT04257136

Run by

Vivacelle Bio

People needed

20

Starts

2020-02-17

Expected to finish

2023-12-31

Last updated by the study team

2023-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 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
• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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