Inflammatory and Metabolic Prognostic Assessment in Critically Ill Neurological Patients

NCT ID: NCT06849011

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1185 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-01

Study Completion Date

2027-03-31

Brief Summary

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The study aims to develop and validate a prognostic prediction model for adverse outcomes in neurocritical patients receiving enteral nutrition based on key inflammatory and metabolic markers. This model will serve as a clinical tool to help physicians identify high-risk patients and guide individualized nutritional support strategies.

Detailed Description

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A multi-center, prospective case data collection study will be conducted across 19 tertiary hospitals in China. Based on this, a predictive assessment model for poor prognosis in neurocritically ill patients receiving enteral nutrition support will be developed and validated, using key inflammatory and metabolic markers. During the data collection process, comprehensive clinical information will be extracted, including patient demographic data, clinical indicators, and hematological markers. By conducting in-depth analysis and processing of this vast and detailed clinical and laboratory data, a nomogram for predicting poor prognosis in neurocritical care patients receiving enteral nutrition support will be constructed using statistical methods and data analysis techniques in R. Once the model is built, it will undergo rigorous validation on an independent external dataset to ensure its accuracy and reliability. The goal is to create a precise assessment tool for clinicians, helping them to quickly and accurately identify high-nutritional-risk patients, thereby providing a solid scientific foundation for the formulation of individualized nutrition support strategies, ultimately improving the prognosis of neurocritical patients.

Conditions

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Stroke Acute Encephalitis Non-traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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mild Inflammation & Metabolic dysfunction

First, a predictive model for poor prognosis is constructed through screening of independent variables after data collection. Then, stratified analysis is conducted with inflammatory markers such as C-reactive protein and interleukin-6, and metabolic markers such as blood glucose and insulin dosage.

No interventions assigned to this group

Moderate Inflammation & Metabolic Dysregulation

First, a predictive model for poor prognosis is constructed through screening of independent variables after data collection. Then, stratified analysis is conducted with inflammatory markers such as C-reactive protein and interleukin-6, and metabolic markers such as blood glucose and insulin dosage.

No interventions assigned to this group

High Inflammation & Severe Metabolic Dysregulation

First, a predictive model for poor prognosis is constructed through screening of independent variables after data collection. Then, stratified analysis is conducted with inflammatory markers such as C-reactive protein and interleukin-6, and metabolic markers such as blood glucose and insulin dosage.

No interventions assigned to this group

Peptide-Based Nutrition

Select patients who received peptide-based formulas from the entire database for poor prognosis analysis.

No interventions assigned to this group

Whole Protein Nutrition

Select patients who received whole protein formulas from the database for poor prognosis analysis.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Age between 18 and 80 years, no gender restrictions.
2. Within 7 days of disease onset and expected NICU stay of at least 7 days.
3. Eligible for enrollment within 24 hours of NICU admission, with enteral nutrition (EN) initiated and continued for at least 7 days.
4. Non-traumatic severe brain injury patients (including cerebrovascular disease and encephalitis) with a Glasgow Coma Scale (GCS) score ≤12.
5. NRS 2002 score ≥3.
6. Kuwata drinking test ≥ grade 3.
7. Acute Gastrointestinal Injury (AGI) grade 1 or 2.
8. Signed informed consent obtained from the patient or their legal representative.

Exclusion Criteria

1. Severe malnutrition prior to admission, defined as BMI \< 16 kg/m².
2. Pregnant or lactating women.
3. Receiving hypothermia treatment or core body temperature \< 36°C.
4. End-stage disease with an expected survival time of \< 48 hours, or severe dysfunction of the heart, lungs, or other vital organs, leading to hemodynamic instability.
5. Malignant tumors.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yan Zhang

OTHER

Sponsor Role lead

Responsible Party

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Yan Zhang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Beijing Hui People's Hospital

Beijing, Beijing Municipality, China

Site Status

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

You'anmen Hospital

Beijing, Beijing Municipality, China

Site Status

The Ninth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status

The 940th Hospital of Joint Logistics Support Force of Chinese PLA

Lanzhou, Gansu, China

Site Status

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Site Status

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Site Status

Tangshan People's Hospital

Tangshan, Hebei, China

Site Status

The First Hospital of Hebei Medical University

Shijiazhuang, Heibei, China

Site Status

Inner Mongolia Autonomous Region People's Hospital

Hohhot, Inner Mongolia, China

Site Status

The Second Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, China

Site Status

The First Hospital of Jilin University

Jilin, Jilin, China

Site Status

Chifeng Municipal Hospital

Chifeng, Neimenggu, China

Site Status

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status

The 960th Hospital of Joint Logistics Support Force of Chinese PLA

Jinan, Shandong, China

Site Status

Liaocheng People's Hospital

Liaocheng, Shandong, China

Site Status

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Site Status

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

Site Status

Countries

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China

Central Contacts

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Yan Zhang, MD., Ph D.

Role: CONTACT

8613671376710

Fei Tian, MD., Ph D.

Role: CONTACT

8618201303685

Facility Contacts

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Yanbo He

Role: primary

8618612691914

Yan Zhang

Role: primary

8613671376710

Dan Xin

Role: primary

8615321688898

Juan Du

Role: primary

8613901362737

Xiaoyan Zhang

Role: primary

8613919931411

Xiao Hu

Role: primary

8618096105119

Zucai Xu

Role: primary

8613368663217

Yan Wang

Role: primary

8613333299772

Jia Tian

Role: primary

8615097392050

Runxiu Zhu

Role: primary

8618047191885

Jijun Shi

Role: primary

8615895551663

Jie Cao

Role: primary

8613756947788

Huijie Zhou

Role: primary

8613948690409

Tao Guo

Role: primary

8613895092758

Qinzhou Wang

Role: primary

8618560085523

Huaiqiang Hu

Role: primary

8613156189722

Dong Guo

Role: primary

8613396258699

Liansheng Ma

Role: primary

8615935111597

Lei Zhang

Role: primary

8613759176858

Other Identifiers

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xwzc202500102

Identifier Type: -

Identifier Source: org_study_id

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