Actively Recruiting

Phase 3
Age: 18Years +
All Genders
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)

Led by Vivacelle Bio · Updated on 2025-04-04

46

Participants Needed

6

Research Sites

68 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

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)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female at least 18 years of age.
  • Evidence of bacterial infection shown by positive blood culture, a known infection source, or elevated procalcitonin of 65 2 ng/ml.
  • Mean blood pressure below 65 mmHg that does not improve with available fluid treatments.
  • Sequential Organ Failure Assessment (SOFA) score of 5 or higher.
  • Sepsis diagnosis confirmed by at least two of the following: lactate > 2 mmol/L, fever > 38.36C, hypothermia < 366C, heart rate over 90, rapid breathing (respiratory rate 65 20/min), abnormal white blood cell count, elevated procalcitonin, arterial hypoxemia, increased creatinine since hospital admission, or coagulation abnormalities.
  • Documented worsening host response shown by a SOFA score increase of 2 or more after infection.
  • Currently receiving vasopressors to keep mean arterial pressure at 65 mmHg.
Not Eligible

You will not qualify if you...

  • Presence of a ventricular assist device.
  • Acute coronary syndrome.
  • Pregnancy.
  • Acute bronchospasm.
  • Acute mesenteric ischemia.
  • Emergency major surgery.
  • Diagnosis of acute Hepatitis B or C.
  • Blood disorders including thrombocytopenia with active bleeding that lowers blood pressure.
  • White blood cell count below 1000 mm3.
  • Participation in another experimental or device study within 30 days before this study, except for COVID-19 drug studies.
  • Known allergy to soybeans or eggs.
  • Hypervolemia confirmed by physician or ultrasound within 12 hours before VBI-S infusion if suspected.
  • Expected to pass away within 12 hours.
  • Disorders of fat metabolism such as pathological hyperlipemia, lipid nephrosis, or acute pancreatitis with hyperlipidemia.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Dignity Health Chandler Regional Medical Center

Chandler, Arizona, United States, 85224

Actively Recruiting

2

Memorial Health University Medical Center

Savannah, Georgia, United States, 31404

Actively Recruiting

3

University Health

Kansas City, Missouri, United States, 64108

Actively Recruiting

4

Bryan Medical Center

Lincoln, Nebraska, United States, 68506

Withdrawn

5

Novant Healthcare

Winston-Salem, North Carolina, United States, 27103

Actively Recruiting

6

Oregon Health & Science University (OHSU)

Portland, Oregon, United States, 97239

Actively Recruiting

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Research Team

C

Cuthbert O Simpkins, MD, FACS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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