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临床试验/NCT07408661
NCT07408661已完成不适用

Application of Artificial Intelligence and Iron Metabolism Markers in Predicting ICU Outcomes for Critically Ill Cancer Patients

Tongji University0 个研究点目标入组 1,137 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,137
主要终点
All-cause Mortality at 30 Days

研究概览

简要总结

This study aimed to develop a more accurate way to predict the 30-day survival of cancer patients admitted to the intensive care unit (ICU). The researchers focused on markers of iron metabolism, as imbalances in iron are common in cancer and severe illness.

The study analyzed data from 1,137 critically ill cancer patients. Using artificial intelligence (AI), specifically a model called TabPFN, the study combined these iron markers with other routine clinical data (like blood cell counts and lactate levels) to create a new prediction tool.

详细描述

Revised Protocol Description (Study Plan):

This retrospective cohort study aims to evaluate whether the integration of artificial intelligence with iron metabolism markers can improve the prediction of 30-day all-cause mortality in critically ill adult cancer patients admitted to the ICU.

Data will be derived from the MIMIC-IV database. Eligible patients will be identified based on predefined inclusion and exclusion criteria. The study will assess the prognostic value of three iron metabolism markers-ferritin, serum iron, and total iron-binding capacity (TIBC)-both individually and in combination with other clinical variables.

Multiple machine learning algorithms will be developed and compared. Feature selection will be performed using methods such as LASSO regression. Candidate models will include, but are not limited to, TabPFN, XGBoost, and Random Forest. Model performance will be evaluated in an independent test set using metrics including the area under the receiver operating characteristic curve (AUC), calibration plots, Brier score, and decision curve analysis.

To ensure model interpretability, SHAP (SHapley Additive exPlanations) analysis will be applied to the final model to identify the most influential predictors. The study protocol has been reviewed and approved by the relevant institutional review boards, and all methods will be conducted in accordance with relevant guidelines and regulations.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (age ≥ 18 years).
  • Diagnosis of any type of cancer, as recorded in the hospital database.
  • First ICU admission during the hospital stay (only the first ICU stay is considered for patients with multiple admissions).

排除标准

  • Length of ICU stay less than 24 hours.
  • Missing or unavailable data for the key study variables, specifically iron metabolism markers (ferritin, serum iron, total iron-binding capacity) or essential clinical parameters needed for analysis.

研究组 & 干预措施

Critically Ill Cancer Patients

This group comprises adult cancer patients who were admitted to the intensive care unit (ICU). The primary interest is in their 30-day all-cause mortality following ICU admission. The cohort includes 1,137 patients whose clinical data was extracted from the MIMIC-IV database. Key variables of interest include iron metabolism markers (ferritin, serum iron, TIBC), routine blood tests, and vital signs, all assessed at or near ICU admission. This retrospective observational study investigates the prognostic value of these markers and aims to develop a machine learning model for predicting mortality risk.

结局指标

主要结局

All-cause Mortality at 30 Days

时间窗: 30 days from the date of ICU admission.

The primary outcome is the incidence of death from any cause within 30 days following the date of ICU admission. Mortality status will be determined by a review of the hospital discharge records and associated death records in the MIMIC-IV database.

次要结局

未报告次要终点

研究者

发起方
Tongji University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Linlin Liu

Clinical Professor

Tongji University

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