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

ConditionsSeptic Shock Sepsis Hypovolemia

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorVivacelle Bio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 and/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

Disqualifiers

Patients with a ventricular assist device

Acute coronary syndrome

Pregnant

Acute bronchospasm

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

46 Participants

are divided into 1 treatment group

Group A: VBI-SExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Elevation in Average Mean Arterial Pressure

The primary endpoint is defined as an elevation in average mean arterial pressure by at least 10 mmHg from baseline within 3 hours of initiation of study treatment on Day 1

Time frame

12 months

Secondary outcomes

Dose of Pressor Drugs

The number 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.

Time frame

12 months

Sequential Organ Failure Assessment (SOFA) Score

Change in Sequential Organ Failure Assessment (SOFA) Score on a scale of 0 to 24. A higher score indicates a worse outcome.

Time frame

12 months

Ratio of Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen

Change in ratio of partial pressure of oxygen in arterial blood/Fraction of inspired oxygen (P/F ratio).

Time frame

12 months

Arterial Oxygen Saturation

Change in arterial oxygen saturation.

Time frame

12 months

Other outcomes

Adverse Drug Reactions

The number and proportion (%) of patients with treatment-emergent adverse drug reactions.

Time frame

12 months

Sponsors and contacts

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Vivacelle Bio

Lead sponsor

Source ClinicalTrials.gov

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