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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

Tracking Information
First Submitted Date  ICMJE February 3, 2020
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date May 20, 2020
Actual Study Start Date  ICMJE February 17, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2020)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients
Official Title  ICMJE VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Septic Shock
  • Sepsis
  • Hypovolemia
Intervention  ICMJE Drug: VBI-S
VBI-S is made of small particles of specific lipid called micelles and liposomes for the treatment of hypotension.
Study Arms  ICMJE Experimental: Treatment
Treatment with VBI-S
Intervention: Drug: VBI-S
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 3, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cuthbert O Simpkins, MD, FACS (318) 771-1294 cuthbert@vivacellebio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04257136
Other Study ID Numbers  ICMJE VBI-S-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vivacelle Bio
Study Sponsor  ICMJE Vivacelle Bio
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cuthbert Simpkins, MD, FACS Vivacelle Bio
PRS Account Vivacelle Bio
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP