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

NCT04257136 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-10-23

No results posted yet for this study

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

Interventions

DRUG

VBI-S

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

Sponsors & Collaborators

  • Vivacelle Bio

    lead INDUSTRY

Principal Investigators

  • Cuthbert Simpkins, MD, FACS · Vivacelle Bio

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-17
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04257136 on ClinicalTrials.gov