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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04257136
• Other study ID #: VBI-S-01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 17, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Vivacelle Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Hypovolemia
• Sepsis
• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• VBI-S
VBI-S is made of small particles of specific lipid called micelles and liposomes for the treatment of hypotension.

Locations

Country	Name	City	State
United States	UMD Shock Trauma	Baltimore	Maryland
United States	Dignity Health	Chandler	Arizona
United States	Henry Ford Health System	Detroit	Michigan
United States	Einstine Medical Center	East Norriton	Pennsylvania
United States	Truman Medical Center	Kansas City	Missouri
United States	Mount Sinai Hospital	New York	New York
United States	Adventist Health Care	Silver Spring	Maryland
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Vivacelle Bio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 Months
Secondary	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	10 Months