Sepsis Clinical Trial
Official title:
Implementation and Prospective Validation of a Sepsis Sub-phenotyping Algorithm Based on Vital Sign Trajectories
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.
Status | Not yet recruiting |
Enrollment | 1200 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All adults who present to the emergency department Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
United States | 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 |
Lead Sponsor | Collaborator |
---|---|
Emory University | National Institute of General Medical Sciences (NIGMS) |
United States,
Bhavani SV, Semler M, Qian ET, Verhoef PA, Robichaux C, Churpek MM, Coopersmith CM. Development and validation of novel sepsis subphenotypes using trajectories of vital signs. Intensive Care Med. 2022 Nov;48(11):1582-1592. doi: 10.1007/s00134-022-06890-z. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | In-hospital mortality | Comparison of 30 day in-hospital mortality rate between the 4 subphenotypes. | Up to 30 days | |
Secondary | Renal replacement therapy (RRT) | Proportion of patients requiring (RRT) during hospital admission. | Through study completion, on average 30 days | |
Secondary | Mechanical ventilation | Proportion of patients requiring mechanical ventilation during hospital admission. | Through study completion, on average 30 days | |
Secondary | Vasopressor use | Proportion of patients requiring vasopressor use during hospital admission. | Through study completion, on average 30 days | |
Secondary | Inotrope use | Proportion of patients requiring inotrope use during hospital admission. | Through study completion, on average 30 days | |
Secondary | Admission to the intensive care unit (ICU) | Proportion of patients requiring admission to ICU during hospital admission. | Through study completion, on average 30 days | |
Secondary | Hospital Length of stay | Duration of hospital length (from arrival to ED until hospital discharge) of stay in days. | Through study completion, on average 30 days | |
Secondary | Response to Balanced Crystalloids vs Normal Saline | Within each subphenotype, the mortality rate will be compared between patients who received at least 2 liters in 24 hours of balanced crystalloids and patients who received normal saline. This is to evaluate the replicability of the finding of a significant mortality benefit from balanced crystalloids in Group D. | 24 hours |
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