Septic ShockPhase 2NCT04257136
VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients
A Phase 2 study testing VBI-S in people with Septic Shock and Sepsis, run by Vivacelle Bio at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Sepsis, Hypovolemia
- What is being tested?
- VBI-S
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 8 sitesUnited States
- Study dates
- 17 Feb 2020to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Lactate > 2 mmol/L
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- Mottled skin
- Decreased capillary refill of nail beds or skin
- Fever > 38.3˚C, or 101˚F
- Hypothermia < 36˚C core temperature (<96.8˚F)
- Heart rate > 90
- Tachypnea
- Change in mental status
- Significant edema or positive fluid balance (>20 mL/kg over 24 hours)
- Hyperglycemia (>140 mg/dL) in someone without diabetes
- White blood cell count >12,000 or less than 4,000, or with >10% "bands" (immature
- forms)
- Elevated C-reactive protein in serum (according to your lab's cutoffs)
- Elevated procalcitonin in serum (≥ 2 ng/ml)
- Arterial hypoxemia (PaO2/FiO2 < 300)
- Acute drop in urine output (<0.5 ml/kg/hr for at least 2 hours despite fluid resuscitation, or about 30 ml/hour for a 70 kg person)
- Creatinine increase > 0.5 mg/dL
- INR > 1.5 or aPTT > 60 seconds
- Absent bowel sounds (ileus)
- High bilirubin (total bilirubin > 4 mg/dL
Who cannot join
- Patients with a ventricular assist device
- Acute coronary syndrome
- Pregnant
- Bronchospasm
- Mesenteric ischemia
- Emergency surgery
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- Acute liver disease (Hepatitis B and C as examples)
- Liver failure with a Model for End-Stage Liver Disease (MELD) score ≥ 19
- Hematologic or coagulation disorders including thrombocytopenia (platelet count <50,000) and associated with hemodynamically significant active bleeding.
- Absolute neutrophil count of < 1000 mm3
- Current participation or participation in another experimental or device study within the last 30 days before the start of this study. Patient may be included if on other drugs for COVID-19 and or septic shock
- Patients with a known allergy to soybeans or eggs
- Patient is hypervolemic as assessed by CVP, ultrasound, Swan Ganz catheter, Flo-Trac, esophageal doppler, bioimpedance, ECHO, Partial carbon dioxide rebreathing (NICO), lithium dilution (LIDCO) or other method published in a peer reviewed journal
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
UMD Shock Trauma
Baltimore, Maryland, 21201
Dignity Health
Chandler, Arizona, 85224
Henry Ford Health System
Detroit, Michigan, 48202
Einstine Medical Center
East Norriton, Pennsylvania, 19403
Truman Medical Center
Kansas City, Missouri, 64108
Mount Sinai Hospital
New York, New York, 10029
Adventist Health Care
Silver Spring, Maryland, 20904
University of Arizona
Tucson, Arizona, 85719
About this 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.
Read the 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
- Conditions
- Septic Shock, Sepsis, Hypovolemia
- Being tested
- VBI-S
- Medical subject headings
- Shock, Septic, Sepsis, Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VBI-SDrug
VBI-S is made of small particles of specific lipid called micelles and liposomes for the treatment of hypotension.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment with VBI-S Receives: Drug: VBI-S |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 10 Months
Secondary outcomes (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
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
Measured: 10 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start17 Feb 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivacelle Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cuthbert Simpkins, MD, FACS, Principal investigator, Vivacelle Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257136
- Sponsor's protocol ID
- VBI-S-01
- Status last verified
- Oct 2023
- First submitted
- 3 Feb 2020
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simpkins C, Moncure M, Klepacz H, Roach K, Benzaquen S, Diaz-Caballero L, Cohen J, Haase D, Kumar M, DeShield H, Manasia A, Rodriguez J, Anamthathmakula P, Hurt N, Mukherjee B, Talluri K. Efficacy and safety of phospholipid nanoparticles (VBI-S) in reversing intractable hypotension in patients with septic shock: a multicentre, open-label, repeated measures, phase 2a clinical pilot trial. EClinicalMedicine. 2024 Jan 29;68:102430. doi: 10.1016/j.eclinm.2024.102430. eCollection 2024 Feb.
PubMed 38545092
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VBI-S for the Treatment of Hypotension in Hypovolemic Septic Shock Patients
- ClinicalTrials.gov ID
- NCT04257136
- Acronym / sponsor ID
- VBI-S-01
- Conditions
- Septic Shock, Sepsis, Hypovolemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vivacelle BioIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: VBI-STreatment with VBI-S |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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:
Key exclusion criteria (13 listed)
- Patients with a ventricular assist device
- Acute coronary syndrome
- Pregnant
- Bronchospasm
- Mesenteric ischemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VBI-SVBI-S is made of small particles of specific lipid called micelles and liposomes for the treatment of hypotension. | Drug | Treatment |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 38545092Simpkins C, Moncure M, Klepacz H, Roach K, Benzaquen S, Diaz-Caballero L, Cohen J, Haase D, Kumar M, DeShield H, Manasia A, Rodriguez J, Anamthathmakula P, Hurt N, Mukherjee B, Talluri K. Efficacy and safety of phospholipid nanoparticles (VBI-S) in reversing intractable hypotension in patients with septic shock: a multicentre, open-label, repeated measures, phase 2a clinical pilot trial. EClinicalMedicine. 2024 Jan 29;68:102430. doi: 10.1016/j.eclinm.2024.102430. eCollection 2024 Feb.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cuthbert Simpkins, MD, FACS principal investigator
Vivacelle Bio
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VBI-S in people with Septic Shock and Sepsis, run by Vivacelle Bio at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04257136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.