Construction of a Prognostic Model for Severe Brain-Injured Patients Based on Integrated Metabolic-Neurological Monitoring

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07198490

Acronym

CPM-Brain

Enrollment

Registered

2025-09-30

Start date

2025-10-01

Completion date

2026-12-31

Last updated

2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries

Keywords

continuous glucose monitoring,Neurological Multimodal Monitoring,Brain Injury,Intensive Care Unit

Brief summary

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).

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
28 days mortality	28 days	all cause mortality at days 28

Contacts

Primary ContactXingui Dai

20685562@qq.com18175708210

Outcome results