CV-SQuISH-ED: Clinical Validation Study

Sepsis Clinical Trial

Official title:

CV-SQuISH-ED: A Clinical Validation Solving the Question of Inflammation or Sepsis Hastily in the Emergency Department

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04933760
• Other study ID #: CV-CLN-007
• Status: Active, not recruiting
• Start date: May 18, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: March 2022
• Source: Cytovale, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a study to evaluate the diagnostic performance of the investigational Cytovale System & IntelliSep Test as a diagnostic marker of sepsis in a population of patients presenting to the emergency department with signs or suspicion of infection compared to retrospective physician adjudication, per the sepsis 3 definition, of those patients.

Description:

This is a multi-site prospective study to evaluate the diagnostic performance of the investigational Cytovale System & IntelliSep Test for patients presenting to the Emergency Department with signs or suspicion of infection. The IntelliSep Test is a microfluidic test that measures the biophysical properties of human leukocytes in conjunction with other laboratory findings and clinical assessments to aid in the early detection of sepsis with organ dysfunction occurring within the first three days after the blood sample collection.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 599
• Est. completion date: May 1, 2022
• Est. primary completion date: January 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. = 18 years old

2. The first vital sign (any one of: blood pressure, temperature, pulse or respiratory rate) has been recorded in the medical record

3. A 300µl blood sample originally collected in a K2 EDTA (hematology purple top) tube within 4 hours of the first recorded vital sign is available.

4. Sign or suspicion of infection, defined as meeting either of criterion A-1 and A-2 (based on temperature, WBC, heart rate, respiratory rate and/or culture order criteria):

Exclusion Criteria:

1. Patients in whom a palliative care or hospice course is expected during ED visit

2. Self-reported, documented or otherwise known to be actively enrolled on any experimental/investigational therapeutic medication prior to blood collection

3. Self-reported, documented, or known history of a hematologic malignancy (any leukemia, lymphoma, or myeloma), myelodysplastic syndrome, or myeloproliferative disorder

4. Self-reported, documented or otherwise known to receive a chemotherapeutic agent or other excluded medication in the past 3 months (Appendix C)

5. Self-reported, documented or otherwise known to have undergone a hematopoietic stem cell transplant or any solid organ transplant

6. Patients transferred to the Emergency Department from another acute care facility

7. Residents or patients of a hospital-based skilled nursing facility

Related Conditions & MeSH terms

• Infection
• Sepsis

Intervention

Diagnostic Test:
• Cytovale IntellipSep test
The Cytovale IntelliSep test measures a series of physical properties that indicate activation of leukocytes obtained from a venous K2-EDTA anti-coagulated whole blood sample.

Locations

Country	Name	City	State
United States	Lady of the Lake Regional Medical Center	Baton Rouge	Louisiana
United States	University of Missouri	Columbia	Missouri
United States	University of Washington	Seattle	Washington
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Cytovale, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IntelliSep Index versus Retrospective Physician Diagnosis (RPD) per the sepsis 3 definition	To validate the diagnostic performance of the investigational Cytovale System & IntelliSep Test as a diagnostic marker of sepsis in a population of patients presenting to the emergency department with signs or suspicion of infection, the IntelliSep test score is compared to the non-reference method of retrospective physician adjudication, per the sepsis 3 definition, of those patients.	30 days