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RECRUITING
NCT06072430
PHASE3

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

Sponsor: Vivacelle Bio

View on ClinicalTrials.gov

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.

Official title: A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2024-08-06

Completion Date

2025-12

Last Updated

2025-04-04

Healthy Volunteers

No

Interventions

DRUG

VBI-S

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

Locations (6)

Dignity Health Chandler Regional Medical Center

Chandler, Arizona, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

University Health

Kansas City, Missouri, United States

Bryan Medical Center

Lincoln, Nebraska, United States

Novant Healthcare

Winston-Salem, North Carolina, United States

Oregon Health & Science University (OHSU)

Portland, Oregon, United States