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临床试验/NCT07198490
NCT07198490尚未招募不适用

Construction of a Prognostic Model for Severe Brain-Injured Patients Based on Integrated Metabolic-Neurological Monitoring: A Prospective Observational Study

Xingui Dai0 个研究点目标入组 50 人开始时间: 2025年10月1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
50
主要终点
Glasgow Outcome Scale Extended (GOSE)

研究概览

简要总结

This is a prospective, observational cohort study aimed at constructing a machine learning-based prognostic model for severe brain-injured patients. The study will synchronously collect continuous glucose monitoring (CGM), electroencephalography (EEG), near-infrared spectroscopy (fNIRS), transcranial Doppler (TCD), and serum neuronal injury biomarkers (NSE, S100β) within 72 hours post-injury. The goal is to investigate the correlation between glycemic variability (GV) and neurological function and to develop an integrated model for early prediction of 3-6 month neurological outcomes (GOSE score).

详细描述

This study intends to enroll 50 adult patients with brain injury admitted to the ICU. Multimodal monitoring data will be collected prospectively. Machine learning algorithms will be used to integrate the data and build a predictive model. The study will test whether integrated metabolic-neurological monitoring outperforms traditional single-parameter prognostic methods.

研究设计

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

入排标准

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

入选标准

  • •Diagnosis of severe TBI, large-volume stroke, or HIE
  • •Expected ICU stay >72 hours
  • •Informed consent from legal surrogate

排除标准

  • •Terminal organ failure
  • •Pre-existing severe neurological disease
  • •Skull defect preventing monitoring
  • •Pregnancy or lactation

结局指标

主要结局

Glasgow Outcome Scale Extended (GOSE)

时间窗: 3 and 6 months

Neurological outcome at 3 and 6 months assessed by Glasgow Outcome Scale Extended (GOSE)

次要结局

  • 28 days mortality(28 days)

研究者

发起方
Xingui Dai
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xingui Dai

The department of Critical Care Medicine

First People's Hospital of Chenzhou

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