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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

Charité University Medicine Berlin logo

Charité University Medicine Berlin

Status

Enrolling

Conditions

Septic Shock
Sepsis

Study type

Observational

Funder types

Other

Identifiers

NCT05383963
QUICK-SEPSIS

Details and patient eligibility

About

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.

Full 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)

Enrollment

10,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • none

Trial contacts and locations

1

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Central trial contact

Claudia Spies, MD, Prof.

Data sourced from clinicaltrials.gov

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