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A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)

(VBI-S-02)

Sponsored by Vivacelle Bio

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...

Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Apr 4, 2025

Phase

Clinical Trial

Sponsor

Vivacelle Bio

Enrollment Target

46

Start Date

Aug 2024

๐Ÿ“Š
1 of 46 participants interested
2% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

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.

Who Can Participate

Inclusion Criteria

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 and/or an elevated procalcitonin of โ‰ฅ 2 ng/ml. 3. Patient has a mean blood pressure \< 65 mmHg that is unresponsive to fluids currently available on the market. 4. Sequential Organ Failure Assessment (SOFA) score โ‰ฅ 5 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
Fever \> 38.3ยฐC, or 101ยฐF
Hypothermia \< 36ยฐC core temperature (\<96.8ยฐF)
Heart rate \> 90
Tachypnea (respiratory rate โ‰ฅ 20/min)
White blood cell count \>12,000 or less than 4,000, or with \>10% "bands" (immature forms)
Elevated procalcitonin in serum (โ‰ฅ 2ng/ml)
Arterial hypoxemia (PaO2/FiO2 \< 300)
Creatinine increase \> 0.5 mg/dL since hospital admission
INR \> 1.5 or aPTT \> 60 seconds 6. Documented dysregulated

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

46 participants

โšง

Gender

ALL

๐Ÿข

Sponsor

Vivacelle Bio

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Chandler

Arizona

Location available
View Chandler location page
RECRUITING

Savannah

Georgia

Location available
View Savannah location page
RECRUITING

Kansas City

Missouri

Location available
View Kansas City location page
WITHDRAWN

Lincoln

Nebraska

Location available
View Lincoln location page
RECRUITING

Winston-Salem

North Carolina

Location available
View Winston-Salem location page
RECRUITING

Portland

Oregon

Location available
View Portland location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Find More Sepsis Trials by City

Browse all sepsis clinical trials in these cities โ€” not just this study.

Looking for Septic Shock Treatment in Chandler?

Join others in Arizona exploring innovative treatment options through clinical research

Septic Shock Treatment Options in Chandler, Arizona

If you're searching for Septic Shock treatment in Chandler, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Chandler, Savannah, Kansas City and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Septic Shock. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 46 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Septic Shock?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Septic Shock

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Septic Shock Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06072430. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.