An observational study in Sepsis, sponsored by Unity Health Toronto. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Unity Health Toronto · Observational
Sepsis is a complex syndrome that affects the functioning of multiple organ systems and is caused by an uncontrolled response to infection. Sepsis is usually diagnosed with a physical examination and evaluation of symptoms followed by lab tests to look at how different organ systems are functioning and to look for signs of infection, which can take up to 3 days. There aren't currently any tests that allow doctors to predict patient outcome, hospital course, or severity of illness. Our team has identified a set of genes that when combined can predict the likelihood of clinical deterioration; this set of genes is called SEPSET. In this study the investigators will evaluate the predictive capability of SEPSET along with clinical and laboratory measures in patients with suspected infection.
The investigators are studying a novel and contemporary paradigm for the management of critically ill patients using molecular (RNA)-based biomarkers to predict clinical deterioration in patients with suspected sepsis.
Building on a successful collaboration with the National Research Council of Canada (NRC), supported by NRC Pandemic Research Challenge Program, by a Natural Sciences and Engineering Research Council of Canada (NSERC) and Canadian Institute of Health Research (CIHR) collaborative grant (CHRP) and Project Grant, our team has developed an RNA-based classifier composed of 4 genes and 2 house-keeping genes (SEPSET) that together, predict the likelihood of clinical deterioration.
In this study, the investigators will prospectively evaluate, compare and combine assessment of the predictive capability of SEPSET, clinical, and laboratory measures to identify patients with suspected sepsis at increased risk for future deterioration, as defined by any of the following: intensive care unit (ICU) admission, initiation of respiratory support (non-invasive ventilatory support), endotracheal intubation, administration of vasopressors/inotropes, or death within the first 72 hours of presentation. Results from SEPSET will be correlated with clinical trajectories evaluated across key clinically relevant endpoints: ventilator liberation, ventilator-free days, duration of mechanical ventilation, ICU length of stay, hospital length of stay, and death at 28-days and 90-days.
1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.
This study's planned enrollment of 400 is above the median of 160 across 957 observational studies indexed under Sepsis.
Browse Sepsis studies →Unity Health Toronto is the lead sponsor of 444 studies on the registry; 80 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with suspicion of infection
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
OR
Exclusion Criteria:
Patients admitted to the Medical Surgical Intensive Care Unit (MSICU) with suspected infection.
Patients admitted to General Internal Medicine (GIM) and General Surgery (GS) with suspected infection.
Patients presenting to the Emergency Department (ED) with suspected infection.
Healthy participants and patients with without infection.
Percent accuracy of the SEPSET 6 gene classifier to predict clinical deterioration when compared to documented clinical deterioration in patients medical charts
Prospective evaluation, comparison, and combinatorial predictive capability of the SEPSET classifier, clinical, and laboratory measures within 24h of presentation, to identify patients with suspected sepsis at increased risk for future deterioration: as defined by any of the following: ICU admission, initiation of respiratory support (mechanical ventilation - non-invasive), endotracheal intubation, administration of vasopressors/inotropes, or death within the first 72h of presentation. The investigators will perform RNA sequencing of 6 genes that have been found to be able to predict clinical deterioration when combined. The likelihood of clinical deterioration determined by using this set of genes will then be compared to actual rates of clinical deterioration based on documented information in the patients medical chart such as need for various types of organ support.
Time frame: 2 years
No study locations are listed for this record.
Plan to share: Undecided — Demographics and Comorbidities - At Enrollment Age and biological sex Self-reported gender Race or ethnicity Past medical history, noting specifically whether the patient has any pre-existing respiratory, cardiovascular, or renal disease Medications at the time of enrollment Previous surgeries Height and admission weight Date of symptom onset Charlson Comorbidity Index Clinical Frailty Scale Physiologic Data - At Enrollment and Daily until day 7 and every 2 weeks until hospital discharge or death Heart rate and rhythm at the time of sample collection or 8am on days when samples are not collected. Maximum and minimum heart rate as well as any documented arrhythmias in the preceding 24 hours Blood pressure and management strategies (i.e. blood pressure medication and dose) at the time of collection or 8am on days when samples are not collected. Maximum and minimum blood pressure in the preceding 24 hours Temperature and management strategies (i.e. paracetamol,
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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