Clinical Trials Logo
  1. Home
  2. Sepsis
  3. NCT06181604
  4. Details
NCT06181604 Clinical Trial

Multicenter Symphony IL-6 Monitoring Sepsis ICU Study

Sepsis Clinical Trial

— SYMON  

Official title:
Multicenter Symphony IL-6 Monitoring Sepsis ICU Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06181604
Other study ID # CES-0007
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 12, 2024
Est. completion date May 30, 2024

Study information
Verified date April 2024
Source Bluejay Diagnostics, Inc.
Contact Clinical Affairs
Phone (844) 327-7078
Email clinical@bluejaydx.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective of this study is to establish an IL-6 concentration cutoff and optimal time point(s) for using Symphony IL-6 that predict 28-day mortality in patients who are admitted or are intended to be admitted to the intensive care unit (ICU) diagnosed with sepsis or septic shock.

Recruitment information / eligibility
Status Recruiting
Enrollment 140
Est. completion date May 30, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility Inclusion Criteria: - Adult patients (=22 years of age) - 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. - Admitted or intended to be admitted to the ICU - At least 0.4ml plasma drawn and available for collection (or is anticipated to be able to be drawn and available) within 12 hours of the earliest diagnosis of sepsis or septic shock. Exclusion Criteria: - Prisoners or imprisonment at time of enrollment - Prior enrollment into this study - Informed consent as approved by IRB is unable to be obtained.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States NewYork-Presbyterian Brooklyn Methodist Hospital Brooklyn New York
United States The Ohio State University/Wexner Medical Center Columbus Ohio
United States Vanderbilt University Medical Center Nashville Tennessee
United States Washington University of St. Louis Saint Louis Missouri
United States Intermountain Healthcare Salt Lake City Utah
United States Wake Forest School of Medicine Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Bluejay Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 28-day all-cause mortality Participants will be followed up for 28 days for all-cause mortality Within 28 days after inclusion
Secondary In-hospital mortality up to 28 days Participants will be followed up for 28 days for in-hospital mortality Within 28 days after inclusion
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05095324 - The Biomarker Prediction Model of Septic Risk in Infected Patients
Completed NCT02714595 - Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens Phase 3
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Completed NCT02867267 - The Efficacy and Safety of Ta1 for Sepsis Phase 3
Completed NCT04804306 - Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
Recruiting NCT05578196 - Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections. N/A
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed NCT03550794 - Thiamine as a Renal Protective Agent in Septic Shock Phase 2
Completed NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Completed NCT04227652 - Control of Fever in Septic Patients N/A
Enrolling by invitation NCT05052203 - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Recruiting NCT04005001 - Machine Learning Sepsis Alert Notification Using Clinical Data Phase 2
Completed NCT03258684 - Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock N/A
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Completed NCT05018546 - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery N/A
Completed NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Not yet recruiting NCT05361135 - 18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia N/A
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3