Novel Sepsis Sub-phenotypes Based on Trajectories of Vital Signs

NCT05826223 | Completed

• 3 other identifiers: STUDY000049705K23GM144867-022022P004808
• Study Type: observational
• Target: 1,916
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Sepsis

Keywords

phenotypes; sub-phenotypes; infection; vital signs; subphenotypes

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality

  Comparison of 30 day in-hospital mortality rate between the 4 subphenotypes.

  Up to 30 days

Secondary Outcomes (7)

• Renal replacement therapy (RRT)

  Through study completion, on average 30 days

• Mechanical ventilation

  Through study completion, on average 30 days

• Vasopressor use

  Through study completion, on average 30 days

• Inotrope use

  Through study completion, on average 30 days

• Admission to the intensive care unit (ICU)

  Through study completion, on average 30 days

Interventions

Implementation and evaluation of a sepsis sub-phenotyping algorithm OTHER

The algorithm will run silently in the background and continuously compute the subphenotypes of patients who are presenting to the emergency department (ED) with suspected infection.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients who present to the emergency department at the participating facilities will automatically be enrolled in the study until the enrollment target for the study is met. All patients will be classified into subphenotypes using the algorithm, but the subgroup that will be analyzed will be patients with suspected infection.

You may qualify if:

• All adults who present to the emergency department

You may not qualify if:

• None

Sponsors & Collaborators

• Emory University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (4)

Emory Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097, United States

Location

Related Publications (1)

• 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. Epub 2022 Sep 24.

  PMID: 36152041 RESULT

MeSH Terms

Conditions

Sepsis; Infections

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sivasubramanium Bhavani, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 24, 2023
• Study Start: September 18, 2025
• Primary Completion: January 14, 2026
• Study Completion: January 14, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)