NCT05383963

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Jul 2022Dec 2027

First Submitted

Initial submission to the registry

May 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

4.1 years

First QC Date

May 17, 2022

Last Update Submit

November 27, 2025

Conditions

SepsisSeptic Shock

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Predictive accuracy

    01.01.2007 -31.12.2021

  • Diagnostic accuracy

    01.01.2007 -31.12.2021

  • Performance indicators

    01.01.2007 -31.12.2021

  • Case costs

    01.01.2007 -31.12.2021

  • Revenues

    01.01.2007 -31.12.2021

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Berlin, 13353, Germany

RECRUITING

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Claudia Spies, MD, Prof.

    Charite University, Berlin, Germany

    STUDY DIRECTOR

Central Study Contacts

Claudia Spies, MD, Prof.

CONTACT

+49 30 450 55 11 02claudia.spies@charite.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin

Study Record Dates

First Submitted

May 17, 2022

First Posted

May 20, 2022

Study Start

July 15, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

December 1, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)