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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sepsis, Septic Shock. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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.
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)
Primary outcome measures
- Sepsis/septic shock [Time frame: 01.01.2007 -31.12.2021]
Secondary outcome measures (5)
- Predictive accuracy [Time frame: 01.01.2007 -31.12.2021]
- Diagnostic accuracy [Time frame: 01.01.2007 -31.12.2021]
- Performance indicators [Time frame: 01.01.2007 -31.12.2021]
- Case costs [Time frame: 01.01.2007 -31.12.2021]
- Revenues [Time frame: 01.01.2007 -31.12.2021]
Eligibility criteria
Inclusion criteria
- age >= 18 years
- ICU stay of > 24 hours
Exclusion criteria
- none
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Univ — Berlin
Identifiers
NCT: NCT05383963 · QUICK-SEPSIS