CV-SQuISH-ED: Clinical Validation Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sepsis; Infection
• Intervention / Treatment: Diagnostic test: Cytovale IntellipSep test

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 599

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Lady of the Lake Regional Medical Center
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients presenting to the Emergency Department with signs or suspicion of infection.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cytovale, Inc.
• Investigators: Principal Investigator: Tonya Jagneaux, MD, Lady of the Lake Regional Medical Center; Principal Investigator: Hariharan Regunath, MD, University of Missouri-Columbia; Principal Investigator: Liza Rosenman, MD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2021
• Primary Completion (Actual): January 13, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Sepsis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: CV-CLN-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No