Treatment for Septic Shock

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Arizona, Tucson, AZSeptic Shock+2 MoreVBI-S - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a drug to see if it can raise blood pressure in patients with septic shock who have low blood volume.

Eligible Conditions
  • Septic Shock
  • Sepsis
  • Low Blood Volume

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
TPE in Septic Shock
1
GEM00220
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lower chloride solutions

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 10 Months

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.
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

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
TPE in Septic Shock
1
GEM00220
2
lower chloride solutions

Trial Design

1 Treatment Group

Treatment
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Treatment · No Placebo Group · Phase 2

Treatment
Drug
Experimental Group · 1 Intervention: VBI-S · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 10 months

Who is running the clinical trial?

Vivacelle BioLead Sponsor
Cuthbert Simpkins, MD, FACSPrincipal InvestigatorVivacelle Bio

Eligibility Criteria

Age 18+ · All Participants · 24 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your heart rate is higher than 90 beats per minute.
Your intestines aren't making any sounds.
You have experienced a change in your ability to think or reason clearly.
Your skin has patchy discoloration.
References

Frequently Asked Questions

Has this method been federally regulated?

"This treatment received a safety rating of 2. This is due to the fact that it is only in Phase 2 trials, meaning while there is evidence supporting its safety, there are no studies yet which suggest it is an effective intervention." - Anonymous Online Contributor

Unverified Answer

Are there a lot of hospitals participating in this research project within the state?

"Currently, this study is enrolling patients at Einstine Medical Center in East Norriton, Pennsylvania, Dignity Health in Chandler, Arizona, and Henry Ford Health System in Detroit, Michigan. There are 10 other locations where recruitment is happening." - Anonymous Online Contributor

Unverified Answer

Is this research still looking for volunteers?

"The listed clinical trial on clinicaltrials.gov is still recruiting patients, with the study having been posted on February 17th, 2020 and edited as recently as October 26th, 2020." - Anonymous Online Contributor

Unverified Answer

What is the total number of participants in this test?

"In order for this clinical trial to move forward, 20 patients that meet the pre-determined criteria must be recruited. The sponsor, Vivacelle Bio, has chosen various locations across America to conduct the trial; two examples are Einstine Medical Center in East Norriton, Pennsylvania and Dignity Health in Chandler, Arizona." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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