About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of severe TBI, large-volume stroke, or HIE
Expected ICU stay >72 hours
Informed consent from legal surrogate
Disqualifiers
Terminal organ failure
Pre-existing severe neurological disease
Skull defect preventing monitoring
Pregnancy or lactation
Trial population
The study population will consist of adult patients (≥18 years old) admitted to the Intensive Care Unit (ICU) of Chenzhou First People's Hospital with a diagnosis of brain injury. This includes patients with:Severe Traumatic Brain Injury (TBI), Expected ICU stay \>72 hours,Informed consent from legal surrogate.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Glasgow Outcome Scale Extended (GOSE)
Neurological outcome at 3 and 6 months assessed by Glasgow Outcome Scale Extended (GOSE)
Secondary outcomes
28 days mortality
all cause mortality at days 28
Locations
Sponsors and contacts
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Xingui Dai
Lead sponsor
First People's Hospital of Chenzhou
Sponsor institution
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