Evaluation of Parameters Collected From Routine Data for the Diagnosis of Sepsis and Septic Shock and Their Influence on Time to Diagnosis and Patient Outcome

Evaluation of Parameters Collected From Routine Data for the Diagnosis of Sepsis and Septic Shock and Their Influence on Time to Diagnosis and Patient Outcome (QUICK-SEPSIS)

Retrospective observational study to develop a Machine Learning Algorithm to evaluate parameters collected from routine data for the diagnosis of sepsis and septic shock and their influence on time to diagnosis and patient outcome.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Septic Shock

Detailed Description

Retrospective routine data from the medical records of the department of anesthesiology and operative intensive care from 01. 01. 2007 to 31. 12. 2021 are analyzed in digital form.

The first step is the development of a machine learning algorithm (MLA). This MLA will be validated and analyzed for his predictive value with regard to early diagnosis of sepsis/septic shock depending on the conceptual value of detection variables (Sepsis-3 vs. SIRS). Further analysis will focus on improvement of accuracy for the MLA and the effect of these detection variables on quality of treatment processes and also on economic consequences like cost and revenue.

Timeline:

1. Conception and development of the ML Algorithm (6 months)
2. Identification and diagnostic validation of sepsis patients (6 months)
3. Secondary analyses (36 months)

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Claudia Spies, MD, Prof.; Phone Number: +49 30 450 55 11 02; Email: claudia.spies@charite.de

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin
    • Sub-Investigator: Andreas Edel, MD
    • Sub-Investigator: Oliver Kumpf, MD
    • Sub-Investigator: Carolin Steffen, MD
    • Sub-Investigator: Fabian Schreiber, MD
    • Principal Investigator: Claudia Spies, MD, Prof.
    • Contact: Claudia Spies, MD, Prof.; Phone Number: +49 30 450 55 11 02; Email: claudia.spies@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Intensive care unit patients (female, male, miscellaneous) from the age of 18 years with an intensive care stay of > 24 hours in an intensive care unit since 01. 01. 2007 from the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK)

Description

Inclusion Criteria:

• age >= 18 years
• ICU stay of > 24 hours

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sepsis/septic shock	Development of a machine learning algorithm (MLA) for the prediction of sepsis/septic shock from hospital routine data.	01.01.2007 -31.12.2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive accuracy	Evaluation of the predictive accuracy (= predictive value) of the respective sepsis diagnostic algorithm (i.e. comparison of the concepts SIRS and Sepsis-3)	01.01.2007 -31.12.2021
Diagnostic accuracy	Identification of additional variables for diagnostic accuracy (laboratory values, clinical parameters and vital-sign monitor parameters and other relevant health data	01.01.2007 -31.12.2021
Performance indicators	Evaluation of performance indicators of clinical routine processes (Intensive care quality indicators)	01.01.2007 -31.12.2021
Case costs	Case costs related to hospitalization	01.01.2007 -31.12.2021
Revenues	Revenues related to hospitalization	01.01.2007 -31.12.2021

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Study Director: Claudia Spies, MD, Prof., Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Shock, Septic; Shock
• Other Study ID Numbers: QUICK-SEPSIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No