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

NCT04257136 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: VBI-S-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 8

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.

Conditions

Septic Shock; Sepsis; Hypovolemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment with VBI-S

Drug: VBI-S

Interventions

VBI-S DRUG

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vivacelle Bio: lead

Study Sites (8)

Dignity Health

Chandler, Arizona, 85224, United States

Location

University of Arizona

Tucson, Arizona, 85719, United States

Location

UMD Shock Trauma

Baltimore, Maryland, 21201, United States

Location

Adventist Health Care

Silver Spring, Maryland, 20904, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Einstine Medical Center

East Norriton, Pennsylvania, 19403, United States

Location

Related Publications (1)

• Simpkins C, Moncure M, Klepacz H, Roach K, Benzaquen S, Diaz-Caballero L, Cohen J, Haase D, Kumar M, DeShield H, Manasia A, Rodriguez J, Anamthathmakula P, Hurt N, Mukherjee B, Talluri K. Efficacy and safety of phospholipid nanoparticles (VBI-S) in reversing intractable hypotension in patients with septic shock: a multicentre, open-label, repeated measures, phase 2a clinical pilot trial. EClinicalMedicine. 2024 Jan 29;68:102430. doi: 10.1016/j.eclinm.2024.102430. eCollection 2024 Feb.

  PMID: 38545092 DERIVED

MeSH Terms

Conditions

Shock, Septic; Sepsis; Hypovolemia

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Cuthbert Simpkins, MD, FACS

  Vivacelle Bio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 5, 2020
• Study Start: February 17, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)