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Not yet recruitingNCT06326385Updated Mar 25, 2024

Machine Learning Predictive Models for Sepsis Risk in ICU Patients With Intracerebral Hemorrhage

An observational study in Intracerebral Hemorrhage and Sepsis, sponsored by Xiangya Hospital of Central South University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2024-03-25.

Sponsored by Xiangya Hospital of Central South University · Observational

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,800
Ages
18 Years to 89 Years
Sex
All
01

Study summary

Patients with intracerebral hemorrhage (ICH) in the intensive care unit (ICU) are at heightened risk of developing sepsis, significantly increasing mortality and healthcare burden. Currently, there is a lack of effective tools for the early prediction of sepsis in ICH patients within the ICU. This study aims to develop a reliable predictive model using machine learning techniques to assist clinicians in the early identification of patients at high risk and to facilitate timely intervention.

The Medical Information Mart for Intensive Care (MIMIC) IV database (version 2.2) is an international online repository for critical care expertise. This database contains patient-related information collected from the ICUs of Beth Israel Deaconess Medical Center between 2008 and 2019. It includes a vast dataset of 299,712 hospital admissions and 73,181 intensive care unit patients.

The eICU Collaborative Research Database (eICU-CRD) comprises data from over 200,000 ICU admissions for 139,367 unique patients across 208 US hospitals between 2014 and 2015, providing a valuable resource for critical care research.

This study aims to establish and validate multiple machine learning models to predict the onset of sepsis in ICU patients with ICH and to identify the model with the optimal predictive performance.

Read the detailed description
  • Data Collection: This study utilized two public databases. The model leveraged clinical data obtained from the Medical Information Mart for Intensive Care (MIMIC) IV database (version 2.2) and selected corresponding patients for external validation from the eICU Collaborative Research Database (eICU-CRD). Data on ICH patients were extracted from the MIMIC IV public database, including baseline characteristics, clinical parameters, therapeutic interventions, and outcomes. The data were randomly divided into two groups, with 70% serving as the training set and 30% as the validation set.
  • Model Development: Feature selection was performed using Lasso regression to construct various machine learning models (such as Random Forest, Logistic Regression, and Neural Networks).
  • Model Validation: In addition to the internal validation set, external validation was also conducted on the eICU database to test the model's generalizability.
  • Statistical Analysis: The predictive performance of the model was evaluated using metrics including the area under the ROC curve (AUC), sensitivity, and specificity.
  • Clinical Applicability Assessment: The clinical utility of the model was assessed using Decision Curve Analysis (DCA).
02

Conditions studied

  • Intracerebral Hemorrhage
  • Sepsis
03

In context

Sepsis

1,894 studies on the registry are indexed under Sepsis; 458 are open to participants now.

This study's planned enrollment of 1,800 is above the median of 160 across 929 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Xiangya Hospital of Central South University is the lead sponsor of 170 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

All diagnoses in the MIMIC-IV and the eICU-CRD databases were identified based on the International Classification of Diseases, Ninth Revision (ICD-9), and ICD-10 codes. For the analysis, patients diagnosed with ICH were included. Sepsis was defined according to the Third International Consensus Definition of Sepsis and Septic Shock (Sepsis-3), which considers patients with suspected infection and a Sequential Organ Failure Assessment (SOFA) score ≥2 as septic.

Inclusion criteria

    1. Diagnosed with primary intracerebral hemorrhage by ICD-9/10 coding.
    1. Aged 19-89 years old.

Exclusion criteria

Exclusion Criteria:

    1. Patients admitted to the hospital but not to the ICU.
    1. Patients with missing follow-up data or incomplete variables.
    1. Patients with a hospital stay exceeding one month.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,800 participants (estimated)
Patient registry
No

Groups and cohorts

  • intracerebral hemorrhage

    Other: no intervention

Interventions

  • Otherno intervention

    no intervention

06

What researchers measure

Primary outcomes

  1. Occurrence of sepsis

    Occurrence of sepsis

    Time frame: within 30 days of admission

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — In the paper

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06326385
Lead sponsor
Xiangya Hospital of Central South University
Responsible party
Sponsor
First posted
Mar 22, 2024
Start date
Mar 30, 2024 (estimated)
Primary completion
May 1, 2024 (estimated)
Completion
May 30, 2024 (estimated)
Last update
Mar 25, 2024

Study contacts

Le Zhang, Doctor
Contact
zlzdzlzd@csu.edu.cn
13973187150
Ye Li, Doctor
Contact
17670516318@163.com
19967131289

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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