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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXingui Dai

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Glasgow Outcome Scale Extended (GOSE)

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

Time frame
3 and 6 months

Secondary outcomes

1

28 days mortality

all cause mortality at days 28

Time frame
28 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xingui Dai

Lead sponsor

First People's Hospital of Chenzhou

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: