VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients (VBI-S-02)

V

Vivacelle Bio

Status and phase

Not yet enrolling
Phase 3
Phase 2

Conditions

Hypovolemia
Septic Shock
Sepsis

Treatments

Drug: VBI-S

Study type

Interventional

Funder types

Industry

Identifiers

NCT06072430
VBI-S-02

Details and patient eligibility

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.

Full 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.

Enrollment

34 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 and/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 and ≤ 11 with the maximum SOFA score of 24.
  • Failure of standard therapy defined as no decrease in the SOFA score for 48 hours or a SOFA score > 11 on admission to the ICU.

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
  • INR > 1.5 or aPTT > 60 seconds

Exclusion criteria

  • Patients with a ventricular assist device
  • Acute coronary syndrome
  • Pregnant
  • Acute bronchospasm
  • Acute Mesenteric ischemia
  • Emergency major surgery
  • Diagnosis of acute Hepatitis B or C
  • Hematologic or coagulation disorders including thrombocytopenia (platelet count < 50,000) and associated with hemodynamically significant active bleeding that causes a decrease in blood pressure
  • White blood cell count of < 1000 mm3
  • Current participation or participation in another experimental or device study with the last 30 days before the start of this study. Patient may be included if on other drugs for COVID-19
  • Patients with a known allergy to soybeans or eggs
  • Patient is hypervolemic as assessed by ultrasound
  • Patient expected to expire within 12 hours

Trial design

34 participants in 1 patient group

VBI-S
Experimental group
Description:
Treatment with VBI-S
Treatment:
Drug: VBI-S

Trial contacts and locations

0

Loading...

Central trial contact

Cuthbert O Simpkins, MD, FACS

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems