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NCT05826223 · ClinicalTrials.gov registry record

Novel Sepsis Sub-phenotypes Based on Trajectories of Vital Signs

A clinical trial, sponsored by Emory University.

Completed
Registry status
1,916
Enrollment target

NCT05826223 is a clinical trial that has completed, run by Emory University. The registered enrollment target is 1,916 participants.

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The verdict

NCT05826223 has completed, sponsored by Emory University.

COMPLETED
Registry status
1,916 participants
Enrollment target

Study 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.

Interventions

  • OTHER Implementation and evaluation of a sepsis sub-phenotyping algorithm

Trial Details

FieldValue
Enrollment Target 1,916 participants
Start Date 2025-09-18
Est. Completion 2026-01-14

Sponsor

Emory University

1,208 total trials

What the Registry Record Tells You About NCT05826223

The ClinicalTrials.gov registry entry for NCT05826223 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,916 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Implementation and evaluation of a sepsis sub-phenotyping algorithm is the first listed.

NCT05826223 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05826223 about?

NCT05826223 is a clinical study titled "Novel Sepsis Sub-phenotypes Based on Trajectories of Vital Signs". 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...

What is the current status of trial NCT05826223?

This trial is currently completed. The enrollment target is 1,916 participants. The study started on 2025-09-18. Estimated completion is 2026-01-14.

What interventions are being tested in trial NCT05826223?

The interventions under investigation include: Implementation and evaluation of a sepsis sub-phenotyping algorithm (OTHER).

Who is sponsoring clinical trial NCT05826223?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.