RECRUITING

Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study

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Conditions

Sepsis, Septic ShockInterleukin-6IL-6Risk StratificationInfectionsToximaSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesSepsisSeptic ShockShock

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to validate a pre-defined IL-6 concentration cutoff that predicts 28-day mortality in patients who are admitted or are intended to be admitted to the ICU diagnosed with sepsis or septic shock.

Official Title

Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study

Quick Facts

Study Start:2024-11-12
Study Completion:2025-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06654895

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients (≥22 years of age)
  2. * Diagnosis of sepsis or septic shock based on: the Third International Consensus Definitions (Sepsis-3 criteria) defined as at least one of the following criteria as determined by a treating physician or study physician investigator.
  3. * Sepsis: suspected or documented infection (i.e., use or intent to use antibiotics as an indicator) and organ dysfunction defined by a Sequential Organ Failure Assessment (SOFA) score ≥2
  4. * Septic shock: sepsis requiring vasopressors and serum lactate levels \>2 mmol/L (18 mg/dL)
  5. * Admitted or intended to be admitted to the ICU
  6. * At least 3 mL plasma drawn and available for collection (or is anticipated to be able to be drawn and available) within 24 hours of (i.e., up to 24 hours after) the earliest diagnosis of sepsis or septic shock.
  1. * Prisoners or imprisonment at time of enrollment
  2. * Prior enrollment into this study
  3. * Informed consent as approved by IRB is unable to be obtained.

Contacts and Locations

Study Contact

Clinical Affairs
CONTACT
844-327-7078
clinical@bluejaydx.com

Study Locations (Sites)

University of Florida College of Medicine
Gainesville, Florida, 32610
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Wake Forest School of Medicine
Winston Salem, North Carolina, 27157
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Intermountain Health
Salt Lake City, Utah, 84111
United States

Collaborators and Investigators

Sponsor: Bluejay Diagnostics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-12
Study Completion Date2025-11-30

Study Record Updates

Study Start Date2024-11-12
Study Completion Date2025-11-30

Terms related to this study

Keywords Provided by Researchers

  • Interleukin-6
  • IL-6
  • Risk Stratification
  • Infections
  • Toxima
  • Systemic Inflammatory Response Syndrome
  • Inflammation
  • Pathologic Processes
  • Sepsis
  • Septic Shock
  • Shock

Additional Relevant MeSH Terms

  • Sepsis, Septic Shock