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SepsisNCT05383963

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

An observational study of Sepsis and Septic Shock, run by Charite University, Berlin, Germany at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis, Septic Shock
How many people
10,000 participants
Where
1 siteGermany
Study dates
15 Jul 2022to Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Who may be able to join

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

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Claudia Spies, MD, Prof. contact

+49 30 450 55 11 02

claudia.spies@charite.de

Germany1 site, 1 recruiting

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

    Berlin, 13353

    Claudia Spies, MD, Prof., +49 30 450 55 11 02, claudia.spies@charite.de

    Claudia Spies, MD, Prof.

    Recruiting

Other trials in Germany

About this study

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)

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.

Read the 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)
Conditions
Sepsis, Septic Shock
Medical subject headings
Sepsis, Shock, Septic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sepsis/septic shock

    Development of a machine learning algorithm (MLA) for the prediction of sepsis/septic shock from hospital routine data.

    Measured: 01.01.2007 -31.12.2021

Secondary outcomes (5)

  1. 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)

    Measured: 01.01.2007 -31.12.2021

  2. Diagnostic accuracy

    Identification of additional variables for diagnostic accuracy (laboratory values, clinical parameters and vital-sign monitor parameters and other relevant health data

    Measured: 01.01.2007 -31.12.2021

  3. Performance indicators

    Evaluation of performance indicators of clinical routine processes (Intensive care quality indicators)

    Measured: 01.01.2007 -31.12.2021

  4. Case costs

    Case costs related to hospitalization

    Measured: 01.01.2007 -31.12.2021

  5. Revenues

    Revenues related to hospitalization

    Measured: 01.01.2007 -31.12.2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2022
  2. Study start15 Jul 2022
  3. Primary completionSep 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05383963
Sponsor's protocol ID
QUICK-SEPSIS
Status last verified
Nov 2025
First submitted
17 May 2022
Last updated
1 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis and Septic Shock, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Claudia Spies, MD, Prof. (+49 30 450 55 11 02, claudia.spies@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sepsis/septic shock (time frame: 01.01.2007 -31.12.2021). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05383963.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.

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