RECRUITING

A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock

Quick Facts

Study Start:2024-08-06

Study Completion:2025-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06072430

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Cuthbert O Simpkins, MD, FACS

CONTACT

3187711294

cuthbert@vivacellebio.com

Principal Investigator

Cuthbert O Simpkins, MD, FACS

PRINCIPAL_INVESTIGATOR

Vivacelle Bio

Study Locations (Sites)

Dignity Health Chandler Regional Medical Center

Chandler, Arizona, 85224

United States

Memorial Health University Medical Center

Savannah, Georgia, 31404

United States

University Health

Kansas City, Missouri, 64108

United States

Bryan Medical Center

Lincoln, Nebraska, 68506

United States

Novant Healthcare

Winston-Salem, North Carolina, 27103

United States

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239

United States

Collaborators and Investigators

Sponsor: Vivacelle Bio

Cuthbert O Simpkins, MD, FACS, PRINCIPAL_INVESTIGATOR, Vivacelle Bio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-06

Study Completion Date2025-07

Study Record Updates

Study Start Date2024-08-06

Study Completion Date2025-07

Terms related to this study

Additional Relevant MeSH Terms

Septic Shock
Sepsis
Hypovolemia