NCT06167083

Brief Summary

Using our own patient data, our study aimed to predict mortality that can develop in Carbapenem-resistant Gram-negative bacilli bloodstream infections with a machine learning-based model. In the intensive care unit, patients with bloodstream infections, both with and without mortality, will be examined retrospectively in two subgroups for comparison.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

April 12, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2025

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

December 4, 2023

Last Update Submit

March 8, 2026

Conditions

Keywords

Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • Risk of Mortality

    The sensitivity and specificity will be defined with AUC-ROC curve (Area Under the Receiver Operating Characteristic curve) using machine learning algorithm

    3 months

Study Arms (2)

Deceased Patients

Carbapenem-resistant Gram-negative bacilli Blood Stream Infection With mortality

Diagnostic Test: Machine Learning to Estimate Mortality

Surviving Patients

Carbapenem-resistant Gram-negative bacilli Blood Stream Infection Without mortality

Diagnostic Test: Machine Learning to Estimate Mortality

Interventions

Using deep learning we try to develop an algorithm and anticipate mortality

Deceased PatientsSurviving Patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who were monitored in our tertiary intensive care unit for six years retrospectively and developed bloodstream infections with Carbapenem-resistant Enterobacteriaceae, Acinetobacter baumannii and Pseudomonas aeruginosa have been included in the study with their personal data anonymized

You may qualify if:

  • In our study, patients who were monitored in our hospital's tertiary Intensive Care Unit between June 2017 and June 2023 and developed bloodstream infections with Carbapenem-resistant Enterobacteriaceae, Carbapenem-resistant Acinetobacter baumannii and Carbapenem-resistant Pseudomonas aeruginosa will be retrospectively included.

You may not qualify if:

  • Patients under the age of 18 and those with infections other than bloodstream infections will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

Related Publications (1)

  • Guler O, Alparslan V, Inner B, Balci S, Duzgun A, Baykara N, Kus A. Machine Learning in the ICU: Predicting Mortality in Patients with Carbapenem-Resistant Gram-Negative Bacilli Bloodstream Infections. J Intensive Care Med. 2026 Mar 16:8850666261423499. doi: 10.1177/08850666261423499. Online ahead of print.

Related Links

Study Officials

  • özlem güler

    Kocaeli University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd Medical Doctor

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 12, 2023

Study Start

April 12, 2024

Primary Completion

June 28, 2025

Study Completion

June 28, 2025

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations