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

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    Vivacelle Bio
Send
Updated on 16 February 2024
See if I qualify
shock
organ failure
vasopressor
procalcitonin
systolic blood pressure
epinephrine
blood culture
vasopressin
sepsis
bacterial infection
pressor
vasoconstrictor
septicemia
septic shock
vasoconstrictors
pressors
adrenal
blood pressure systolic
dopamine

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.

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

Details
Condition Septicemia, Hypovolemia, Toxic Shock Syndrome
Age 18years - 100years
Treatment VBI-S
Clinical Study IdentifierNCT04257136
SponsorVivacelle Bio
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
Patient has a mean blood pressure < 65 mmHg that is unresponsive to fluids currently available on the market
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%)
Sequential Organ Failure Assessment (SOFA) score >=15 (Predicted mortality >80%)
Systolic blood pressure < 90 mm Hg (or a drop of > 40 mm Hg from baseline)
Sepsis diagnosis

Exclusion Criteria

Patients with a ventricular assist device
Acute coronary syndrome
Pregnant
Bronchospasm
Mesenteric ischemia
Emergency surgery
History of liver disease (Hepatitis B and C), chronic hepatic failure and /or cirrhosis
Liver failure with a Model for End-Stage Liver Disease (MELD) score 19
Clinically significant hematologic or coagulation disorders including thrombocytopenia (platelet count <50,000)
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
Patients with a known allergy to soybeans or eggs
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

shock
organ failure
vasopressor
procalcitonin
systolic blood pressure
epinephrine
blood culture
vasopressin
sepsis
bacterial infection
pressor
vasoconstrictor
septicemia
septic shock
vasoconstrictors
pressors
adrenal
blood pressure systolic
dopamine

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.