UnknownPhase 2

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

United States20 participantsStarted 2020-02-17

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 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.
✓. Sepsis diagnosis: The presence of infection which can be proven or suspected by 2 or more of the following criteria:

Exclusion criteria

✕. Patients with a ventricular assist device
✕. Acute coronary syndrome
✕. Pregnant
✕. Bronchospasm
✕. Mesenteric ischemia
✕. Emergency surgery
✕. Acute liver disease (Hepatitis B and C as examples)
✕. Liver failure with a Model for End-Stage Liver Disease (MELD) score ≥ 19

What they're measuring

The primary endpoint of this study is the proportion of patients in whom mean blood pressure increased by at least 10 mmHg with a mean blood pressure target of 60 - 65 mmHg.

Timeframe: 10 Months

Trial details

NCT IDNCT04257136

SponsorVivacelle Bio

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-31

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