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

NCT07198490 | Not Yet Recruiting DMC

• 1 other identifier: Chenzhou People's Hospital
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Brain Injuries

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Glasgow Outcome Scale Extended (GOSE)

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

  3 and 6 months

Secondary Outcomes (1)

• 28 days mortality

  28 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xingui Dai: lead

Related Publications (3)

• Jones S, Schwartzbauer G, Jia X. Brain Monitoring in Critically Neurologically Impaired Patients. Int J Mol Sci. 2016 Dec 27;18(1):43. doi: 10.3390/ijms18010043.

  PMID: 28035993 BACKGROUND

• Miller C, Armonda R; Participants in the International Multi-disciplinary Consensus Conference on Multimodality Monitoring. Monitoring of cerebral blood flow and ischemia in the critically ill. Neurocrit Care. 2014 Dec;21 Suppl 2:S121-8. doi: 10.1007/s12028-014-0021-9.

  PMID: 25208667 BACKGROUND

• Gandee R, Miller C. Multimodality Monitoring: Toward Improved Outcomes. Semin Respir Crit Care Med. 2017 Dec;38(6):785-792. doi: 10.1055/s-0037-1608774. Epub 2017 Dec 20.

  PMID: 29262436 RESULT

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Xingui Dai

CONTACT

18175708210; 20685562@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The department of Critical Care Medicine

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09