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临床试验/NCT06326385
NCT06326385尚未招募不适用

Development and Validation of Predictive Models for Sepsis Risk in Patients With Intracerebral Hemorrhage in Intensive Care Units Based on Machine Learning: A Retrospective Cohort Study

Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2024年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,800
试验地点
1
主要终点
Occurrence of sepsis

研究概览

简要总结

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.

详细描述

  • 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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Occurrence of sepsis

时间窗: within 30 days of admission

Occurrence of sepsis

次要结局

未报告次要终点

研究者

发起方
Xiangya Hospital of Central South University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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