- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06167083
Machine Learning in the ICU: Predicting Mortality in Bloodstream Infections (ICU:Intensive Care Unit) (ICU)
Machine Learning in the ICU: Predicting Mortality in Patients With Carbapenem-Resistant Gram-Negative Bacilli Bloodstream Infections
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Carbapenems are one of the last-resort antibiotics used to treat severe infections caused by multi-drug resistant Gram-negative pathogens. Infections with Carbapenem-resistant Gram-negative bacilli (CR-GNB) have become widespread in the past decade, posing serious threats to public health. Carbapenem-resistant Enterobacteriaceae (CRE), Carbapenem-resistant Acinetobacter baumannii (CRAB), and Carbapenem-resistant Pseudomonas aeruginosa (CRPA) top the priority list of antibiotic-resistant bacteria worldwide. CR-GNB causes a broad spectrum of infections, including bacteremia, urinary tract infections, pneumonia, and intra-abdominal infections. Carbapenem-resistant bloodstream infections are a significant cause of morbidity and mortality, and therapeutic options in treatment are extremely limited. By evaluating risk factors in patients monitored in the intensive care unit, scoring systems that can predict prognosis reduce mortality risk by ensuring the early application of effective antibiotics and timely hemodynamic support that are currently in use.
With the accumulation of big data and advancements in data storage techniques, innovative and pragmatic machine learning methods that have entered our lives demonstrate good prediction performance in the medical field. Machine learning-based models developed to predict mortality in patients monitored in the intensive care unit are available in the literature and provide an opportunity for earlier intervention in patients.
Using our own patient data, In the intensive care unit, patients with bloodstream infections, both with and without mortality, will be examined retrospectively in two subgroups for comparison. The investigators aim to predict mortality that can develop in Carbapenem-resistant Gram-negative bacilli bloodstream infections with a machine learning-based model.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
-
Kocaeli, Turkey (Türkiye)
- Kocaeli University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients under the age of 18 and those with infections other than bloodstream infections will not be included.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Deceased Patients
Carbapenem-resistant Gram-negative bacilli Blood Stream Infection With mortality
|
Using deep learning we try to develop an algorithm and anticipate mortality
|
|
Surviving Patients
Carbapenem-resistant Gram-negative bacilli Blood Stream Infection Without mortality
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Using deep learning we try to develop an algorithm and anticipate mortality
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk of Mortality
Time Frame: 3 months
|
The sensitivity and specificity will be defined with AUC-ROC curve (Area Under the Receiver Operating Characteristic curve) using machine learning algorithm
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: özlem güler, Kocaeli University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GOKAEK-2023/12.31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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