Construction of a Prognostic Model for Severe Brain-Injured Patients Based on Integrated Metabolic-Neurological Monitoring
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Brain Injuries. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Construction of a Prognostic Model for Severe Brain-Injured Patients Based on Integrated Metabolic-Neurological Monitoring: A Prospective Observational Study
Overview
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.
Primary outcome measures
- Glasgow Outcome Scale Extended (GOSE) [Time frame: 3 and 6 months]
Secondary outcome measures (1)
- 28 days mortality [Time frame: 28 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
- 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
- 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
Identifiers
NCT: NCT07198490 · Chenzhou People's Hospital