Evaluating biomarkers for infection and inflammation in sepsis
Early Detection of Inflammatory Biomarkers in Infection
This study is testing new blood markers to see if they can help doctors identify patients with sepsis who are at risk for serious problems, so they can provide better care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT02545478 on ClinicalTrials.gov |
What this trial studies
This investigation aims to assess the effectiveness of early biomarkers in identifying patients at risk for poor outcomes in sepsis and septic shock. It focuses on the body's immune response and inflammatory markers that may indicate the severity of infection. Current laboratory parameters like white blood cell count and CRP are commonly used but are not always reliable, prompting the need for better predictive tests. By understanding the host response to infection, the study seeks to improve patient management and treatment strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed or suspected infections.
Not a fit: Patients with non-infectious clinical presentations or those who are suspected of having an infection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and treatment of sepsis, potentially saving lives.
How similar studies have performed: Other studies have explored biomarkers in sepsis, but this approach may provide novel insights into early detection and management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for Infected subjects: * Age 18 years of age or older * Confirmed or suspected infection Inclusion Criteria for Control Subjects: * Age 18 years of age or older * A non-infectious clinical presentation to include * Normal white blood cell count ( \> 4,000 and/or \< 12,000) * Normothermia ( \> 96.5 and/or less 100.4) * Absence of the following clinical complaints: productive cough, fever, pyuria, rash * No evidence of acute coronary syndrome Exclusion Criteria for Control Subjects: \- Suspected infection
Where this trial is running
Boston, Massachusetts and 1 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Active_not_recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Nathan Shapiro, MD MPH — Beth Israel Deaconess Medical Center
- Study coordinator: Nathan Shapiro, MD MPH
- Email: nshapiro@bidmc.harvard.edu
- Phone: 617-754-2343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.