CV-SQuISH-ED: Clinical Validation Study

NCT ID: NCT04933760

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 599 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-18
• Study Completion Date: 2022-05-01

Brief 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.

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.

Conditions

Sepsis; Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cytovale, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tonya Jagneaux, MD

Role: PRINCIPAL_INVESTIGATOR

Lady of the Lake Regional Medical Center

Hariharan Regunath, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Liza Rosenman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Simon Mahler, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, United States

University of Missouri

Columbia, Missouri, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

CV-CLN-007

Identifier Type: -

Identifier Source: org_study_id