Clinical Trials Logo

Clinical Trial Summary

Sepsis is a severe response to infection resulting in organ dysfunction and often leading to death. More than 1.5 million people get sepsis every year in the U.S., and 270,000 Americans die from sepsis annually. Delays in the diagnosis of sepsis lead to increased mortality. Several clinical decision support algorithms exist for the early identification of sepsis. The research team will compare the performance of three sepsis prediction algorithms to identify the algorithm that is most accurate and clinically actionable. The algorithms will run in the background of the electronic health record (EHR) and the predictions will not be revealed to patients or clinical staff. In this current evaluation study, the algorithms will not affect any part of a patient's care. The algorithms will be deployed across the Emory healthcare system on data from all patients presenting to the emergency department.


Clinical Trial Description

The primary goal of this study is to prospectively evaluate three sepsis prediction algorithms that are embedded in the EHR. The models will be deployed in a "shadow" mode, and the results will not be displayed to the treatment team during this study. Two of the algorithms are proprietary algorithms of the EHR provider (Epic). The third algorithm is an internally developed, open-source algorithm. The algorithms will compute the probability of sepsis at periodic intervals and will continue to run on a patient's data until the patient's discharge, death, or upon initiation of intravenous antibiotics (at which point there is an indirect record of clinical suspicion of an infection). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05943938
Study type Observational
Source Emory University
Contact Sivasubramanium Bhavani, MD
Phone 404-712-2970
Email sivasubramanium.bhavani@emory.edu
Status Not yet recruiting
Phase
Start date August 2024
Completion date December 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05095324 - The Biomarker Prediction Model of Septic Risk in Infected Patients
Completed NCT02714595 - Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens Phase 3
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Completed NCT02867267 - The Efficacy and Safety of Ta1 for Sepsis Phase 3
Completed NCT04804306 - Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
Recruiting NCT05578196 - Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections. N/A
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed NCT03550794 - Thiamine as a Renal Protective Agent in Septic Shock Phase 2
Completed NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Completed NCT04227652 - Control of Fever in Septic Patients N/A
Enrolling by invitation NCT05052203 - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Recruiting NCT04005001 - Machine Learning Sepsis Alert Notification Using Clinical Data Phase 2
Completed NCT03258684 - Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock N/A
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Completed NCT05018546 - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery N/A
Completed NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Not yet recruiting NCT05361135 - 18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia N/A
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3