NCT04257136

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Vivacelle Bio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Septic Shock
• Sepsis
• Hypovolemia

Interventions

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

Timeline

• Start date: 2020-02-17
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2020-02-05
• Last updated: 2023-10-23

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study