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

Primary Purpose

Septic Shock, Sepsis, Hypovolemia

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VBI-S
Sponsored by
Vivacelle Bio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dignity Health
  • University of Arizona
  • UMD Shock Trauma
  • Adventist Health Care
  • Henry Ford Health System
  • Truman Medical Center
  • Mount Sinai Hospital
  • Einstine Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Treatment with VBI-S

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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

Full Information

First Posted
February 3, 2020
Last Updated
October 19, 2023
Sponsor
Vivacelle Bio
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1. Study Identification

Unique Protocol Identification Number
NCT04257136
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 17, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vivacelle Bio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Sepsis, Hypovolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment with VBI-S
Intervention Type
Drug
Intervention Name(s)
VBI-S
Intervention Description
VBI-S is made of small particles of specific lipid called micelles and liposomes for the treatment of hypotension.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
10 Months
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
10 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cuthbert Simpkins, MD, FACS
Organizational Affiliation
Vivacelle Bio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dignity Health
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
UMD Shock Trauma
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Adventist Health Care
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20904
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Truman Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Einstine Medical Center
City
East Norriton
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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