RECRUITING

Novel Sepsis Sub-phenotypes Based on Trajectories of Vital Signs

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Implementation and Prospective Validation of a Sepsis Sub-phenotyping Algorithm Based on Vital Sign Trajectories

Quick Facts

Study Start:2025-09-18
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05826223

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All adults who present to the emergency department
  1. * None

Contacts and Locations

Study Contact

Sivasubramanium Bhavani, MD
CONTACT
404-712-2970
sivasubramanium.bhavani@emory.edu

Principal Investigator

Sivasubramanium Bhavani, MD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Emory Hospital Midtown
Atlanta, Georgia, 30308
United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30308
United States
Emory University Hospital
Atlanta, Georgia, 30322
United States
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097
United States

Collaborators and Investigators

Sponsor: Emory University

  • Sivasubramanium Bhavani, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-18
Study Completion Date2026-01

Study Record Updates

Study Start Date2025-09-18
Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

  • phenotypes
  • sub-phenotypes
  • infection
  • vital signs
  • subphenotypes

Additional Relevant MeSH Terms

  • Sepsis