Novel Sepsis Sub-phenotypes Based on Trajectories of Vital Signs
Completed
Conditions studied: Sepsis
In brief
Sepsis is a dysregulated host response to infection resulting in organ dysfunction. Over the past three decades, more than 30 pharmacological therapies have been tested in \>100 clinical trials and have failed to show consistent benefit in the overall population of patients with sepsis. The one-size-fits-all approach has not worked. This has resulted in a shift in research towards identifying sepsis subphenotypes through unsupervised learning. The ultimate objective is to identify sepsis subphenotypes with different responses to therapies, which could provide a path towards the precision medicine approach to sepsis. The investigators have previously discovered sepsis subphenotypes in retrospective data using trajectories of vital signs in the first 8 hours of hospitalization. The team aims to prospectively classify adult hospitalized patients into these subphenotypes in a prospective, observational study. This will be done through the implementation of an electronic health record integrated application that will use vital signs from hospitalized patients to classify the patients into one of four subphenotypes. This study will continue until 1,200 patients with infection are classified into the sepsis subphenotypes. The classification of the patients is only performed to validate the association of the subphenotypes with clinical outcomes as was shown in retrospective studies. Physicians and providers treating the patients will not see the classification, and the algorithm classifying the patients will in no way affect the care of the patients. Further, all the data needed for the algorithm (vital signs from the first 8 hours) are standard of care, and enrollment in the prospective study does not require any additional data.
Key facts
- Study ID
- NCT05826223
- Run by
- Emory University
- People needed
- 1916
- Starts
- 2025-09-18
- Expected to finish
- 2026-01-14
- Last updated by the study team
- 2026-02-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All adults who present to the emergency department
You may not qualify if…
- None
Where it is running
- Emory Hospital Midtown — Atlanta, Georgia, United States
- Emory Saint Joseph's Hospital — Atlanta, Georgia, United States
- Emory University Hospital — Atlanta, Georgia, United States
- Emory Johns Creek Hospital — Johns Creek, Georgia, United States
Full record on ClinicalTrials.gov
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