Actively Recruiting
Early Detection of Inflammatory Biomarkers in Infection
Led by Beth Israel Deaconess Medical Center · Updated on 2026-04-15
4200
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating early biomarkers of infection and inflammation to identify patients at risk for poor outcomes in sepsis and septic shock. The study focuses on measuring immune response markers like cytokines, clotting factors, and endothelial markers to better understand sepsis severity and patient risk. It is a multicenter observational pilot study comparing patients with suspected infection to a non-infected control group. Participants include patients suspected of infection and a control group without infection. Blood samples and chart reviews are collected at enrollment, 24, 48, and 72 hours for the infected group, while controls have a single blood draw at enrollment. Additional assessments include non-invasive imaging techniques like orthogonal polarization spectroscopy, echocardiography, diffuse correlation spectroscopy, and measurements of microvascular flow and endothelial glycocalyx degradation. Throughout the study, participants undergo physiological assessments such as echocardiography and microcirculation imaging. Researchers track outcomes including 28-day in-hospital mortality and organ dysfunction by SOFA score within 24 hours. The study involves urine sample collection for some patients and uses various non-invasive monitors to gather detailed information on the body's response to infection and inflammation over several days.
CONDITIONS
Brief Title
Biomarkers in Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years of age or older
- Confirmed or suspected infection (for infected subjects)
- Age 18 years of age or older (for control subjects)
- Non-infectious clinical presentation for control subjects
- Normal white blood cell count (greater than 4,000 and/or less than 12,000) for control subjects
- Normothermia (greater than 96.5 and/or less than 100.4) for control subjects
- Absence of clinical complaints such as productive cough, fever, pyuria, or rash for control subjects
- No evidence of acute coronary syndrome for control subjects
You will not qualify if you...
- Suspected infection (for control subjects)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 72 hours for infected participants; single time point for non-infected controls
Participants with suspected infection and non-infected participants are observed with blood draws and physiologic assessments to evaluate inflammatory and infection biomarkers.
Infected group: 4 visits (in-person) at enrollment, 24, 48, and 72 hours; Non-infected group: 1 visit (in-person) at enrollment
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Active, Not Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
N
Nathan Shapiro, MD MPH
C
Carlo Ottanelli, BSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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