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

NCT ID: NCT05383963

Last Updated: 2025-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-15

Study Completion Date

2027-12-31

Brief Summary

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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

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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)

Conditions

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Sepsis Septic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* age \>= 18 years
* ICU stay of \> 24 hours

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Claudia Spies

Head of the Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia Spies, MD, Prof.

Role: STUDY_DIRECTOR

Charite University, Berlin, Germany

Locations

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Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Claudia Spies, MD, Prof.

Role: CONTACT

+49 30 450 55 11 02

Facility Contacts

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Claudia Spies, MD, Prof.

Role: primary

+49 30 450 55 11 02

Other Identifiers

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QUICK-SEPSIS

Identifier Type: -

Identifier Source: org_study_id

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