Inflammatory and Metabolic Prognostic Assessment in Critically Ill Neurological Patients
NCT ID: NCT06849011
Last Updated: 2025-02-27
Study Results
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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NOT_YET_RECRUITING
1185 participants
OBSERVATIONAL
2025-03-01
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Yan Zhang
OTHER
Responsible Party
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Yan Zhang
Professor
Locations
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Beijing Hui People's Hospital
Beijing, Beijing Municipality, China
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
You'anmen Hospital
Beijing, Beijing Municipality, China
The Ninth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
The 940th Hospital of Joint Logistics Support Force of Chinese PLA
Lanzhou, Gansu, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
Tangshan People's Hospital
Tangshan, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Heibei, China
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, China
The Second Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China
The First Hospital of Jilin University
Jilin, Jilin, China
Chifeng Municipal Hospital
Chifeng, Neimenggu, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
The 960th Hospital of Joint Logistics Support Force of Chinese PLA
Jinan, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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xwzc202500102
Identifier Type: -
Identifier Source: org_study_id
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