VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Treatment with VBI-S |
Drug: VBI-S
VBI-S is made of small particles of specific lipid called micelles and liposomes for the treatment of hypotension.
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Outcome Measures
Primary Outcome Measures
- 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. [10 Months]
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.
Secondary Outcome Measures
- The secondary endpoint of this study is the proportion 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 [10 Months]
The secondary endpoint of this study is the proportion 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female at least 18 years of age
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Evidence of bacterial infection demonstrated by positive blood culture and/or a known source of infection or an elevated procalcitonin.
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Patient has a mean blood pressure < 65 mmHg that is unresponsive to fluids currently available on the market.
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Patient is on two or more pressor drugs at the following minimal doses: Levophed =20 mcg/minute, epinephrine 10 mcg/minute, dopamine 20 mcg/kg/minute, phenylephrine 180mcg/minute, vasopressin 4 units/hour, at full dose required to maintain a mean blood pressure of 65 mmHg or Patient is on Levophed or its equivalent at 55 mcg/min with conversion factors for other vasopressors to Levophed being 5.6 x Vasopressin ( in units/hour), 0.5 x dopamine( in mcg/kg/minute) epinephrine ( in mcg/minute) 0.1 x phenylephrine ( in mcg/minute) at full dose to maintain a mean blood pressure of 65 mmHg. (Predicted mortality >80%)
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Sequential Organ Failure Assessment (SOFA) score >=15 (Predicted mortality >80%)
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Systolic blood pressure < 90 mm Hg (or a drop of > 40 mm Hg from baseline)
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Sepsis diagnosis
Exclusion Criteria:
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Patients with a ventricular assist device
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Acute coronary syndrome
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Pregnant
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Bronchospasm
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Mesenteric ischemia
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Emergency surgery
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History of liver disease (Hepatitis B and C), chronic hepatic failure and /or cirrhosis
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Liver failure with a Model for End-Stage Liver Disease (MELD) score ≥ 19
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Clinically significant hematologic or coagulation disorders including thrombocytopenia (platelet count <50,000)
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Absolute neutrophil count of < 1000 mm3
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Current participation or participation in another experimental or device study within the last 30 days before the start of this study
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Patients with a known allergy to soybeans or eggs
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fort Wayne | Fort Wayne | Indiana | United States | 46804 |
| 2 | Indiana | Fort Wayne | Indiana | United States | 46804 |
Sponsors and Collaborators
- Vivacelle Bio
Investigators
- Principal Investigator: Cuthbert Simpkins, MD, FACS, Vivacelle Bio
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VBI-S-01