A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Vivacelle Bio
Study ID
NCT06072430
Phase
PHASE3
Status
Recruiting
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Conditions

  • Hypovolemia
  • Sepsis
  • Septic Shock

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VBI-S — DRUG
    VBI-S is made of small particles of specific lipids called micelles and liposomes for the treatment of hypotension.

Study Details

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.

Key Dates

Start date
Aug 6, 2024
Status verified
Apr 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
46 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VBI-S
    Treatment with VBI-S

Primary Outcome Measure

Elevation in Average Mean Arterial Pressure [ Time Frame: 12 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Dignity Health Chandler Regional Medical CenterChandlerArizona85224
Kristopher Roach, MD
Memorial Health University Medical CenterSavannahGeorgia31404
Domenick Roma, MD
University HealthKansas CityMissouri64108
Michael Moncure, MD
Bryan Medical CenterLincolnNebraska68506-
Novant HealthcareWinston-SalemNorth Carolina27103
Daniel Feinstein, MD
Oregon Health & Science University (OHSU)PortlandOregon97239
Akram Khan, MD

Find similar trials in Chandler, AZ

By research site
Dignity Health Chandler Regional Medical Center· Chandler, AZMemorial Health University Medical Center· Savannah, GAUniversity Health· Kansas City, MOBryan Medical Center· Lincoln, NENovant Healthcare· Winston-Salem, NCOregon Health & Science University (OHSU)· Portland, OR

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