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

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ClinicalTrials.gov Identifier: NCT04257136
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Vivacelle Bio

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
Septic Shock Sepsis Hypovolemia Drug: VBI-S 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients
Actual Study Start Date : February 17, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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. [ Time Frame: 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 :
  1. 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 [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female at least 18 years of age
  2. Evidence of bacterial infection demonstrated by positive blood culture and/or a known source of infection or an elevated procalcitonin.
  3. Patient has a mean blood pressure < 65 mmHg that is unresponsive to fluids currently available on the market.
  4. 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%)
  5. Sequential Organ Failure Assessment (SOFA) score >=15 (Predicted mortality >80%)
  6. Systolic blood pressure < 90 mm Hg (or a drop of > 40 mm Hg from baseline)
  7. Sepsis diagnosis

Exclusion Criteria:

  1. Patients with a ventricular assist device
  2. Acute coronary syndrome
  3. Pregnant
  4. Bronchospasm
  5. Mesenteric ischemia
  6. Emergency surgery
  7. History of liver disease (Hepatitis B and C), chronic hepatic failure and /or cirrhosis
  8. Liver failure with a Model for End-Stage Liver Disease (MELD) score ≥ 19
  9. Clinically significant hematologic or coagulation disorders including thrombocytopenia (platelet count <50,000)
  10. Absolute neutrophil count of < 1000 mm3
  11. Current participation or participation in another experimental or device study within the last 30 days before the start of this study
  12. Patients with a known allergy to soybeans or eggs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04257136


Contacts
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Contact: Cuthbert O Simpkins, MD, FACS (318) 771-1294 cuthbert@vivacellebio.com

Locations
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United States, Indiana
Fort Wayne Recruiting
Fort Wayne, Indiana, United States, 46804
Indiana Recruiting
Fort Wayne, Indiana, United States, 46804
Sponsors and Collaborators
Vivacelle Bio
Investigators
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Principal Investigator: Cuthbert Simpkins, MD, FACS Vivacelle Bio
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Responsible Party: Vivacelle Bio
ClinicalTrials.gov Identifier: NCT04257136    
Other Study ID Numbers: VBI-S-01
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shock, Septic
Hypotension
Shock
Hypovolemia
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Vascular Diseases
Cardiovascular Diseases