Inflammatory and Metabolic Prognostic Assessment in Critically Ill Neurological Patients
IMPACT-NEURO
Development and Validation of a Prognostic Prediction Model for Adverse Outcomes in Neurocritical Patients Receiving Enteral Nutrition Based on Key Inflammatory and Metabolic Markers
1 other identifier
observational
1,185
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2025
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2025
CompletedFirst Posted
Study publicly available on registry
February 27, 2025
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
February 27, 2025
February 1, 2025
1.8 years
February 12, 2025
February 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause mortality at Day 28 of enteral nutrition therapy
From enrollment to 28 days after the initiation of enteral nutrition
Secondary Outcomes (12)
Nutritional goal achievement rate at Day 3 (caloric and protein intake reaching 70%-100% of calculated target)
At Day 3 after the initiation of enteral nutrition
Adverse outcome rate at Day 90 (defined as a Modified Rankin Scale score ≥ 3)
At Day 90 after the initiation of enteral nutrition
Incidence of infectious complications within 14 days (including pneumonia, urinary tract infections, bloodstream infections, skin infections, and Clostridium difficile infections)
Within 14 days after the initiation of enteral nutrition
Gastrointestinal intolerance within 14 days (gastric residual volume > 200 mL, nausea, vomiting, bloating, diarrhea)
Within 14 days after the initiation of enteral nutrition
Incidence of gastrointestinal bleeding within 14 days (gastric occult blood, fecal occult blood, hematemesis, melena, hematochezia)
Within 14 days after the initiation of enteral nutrition
- +7 more secondary outcomes
Study Arms (5)
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.
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.
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.
Peptide-Based Nutrition
Select patients who received peptide-based formulas from the entire database for poor prognosis analysis.
Whole Protein Nutrition
Select patients who received whole protein formulas from the database for poor prognosis analysis.
Eligibility Criteria
The study population consists of critically ill neurocritical patients in the acute phase who are receiving enteral nutrition (EN) treatment in the Neurocritical Care Unit (NICU).
You may qualify if:
- Age between 18 and 80 years, no gender restrictions.
- Within 7 days of disease onset and expected NICU stay of at least 7 days.
- Eligible for enrollment within 24 hours of NICU admission, with enteral nutrition (EN) initiated and continued for at least 7 days.
- Non-traumatic severe brain injury patients (including cerebrovascular disease and encephalitis) with a Glasgow Coma Scale (GCS) score ≤12.
- NRS 2002 score ≥3.
- Kuwata drinking test ≥ grade 3.
- Acute Gastrointestinal Injury (AGI) grade 1 or 2.
- Signed informed consent obtained from the patient or their legal representative.
You may not qualify if:
- Severe malnutrition prior to admission, defined as BMI \< 16 kg/m².
- Pregnant or lactating women.
- Receiving hypothermia treatment or core body temperature \< 36°C.
- 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.
- Malignant tumors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yan Zhanglead
Study Sites (19)
Beijing Hui People's Hospital
Beijing, Beijing Municipality, 100053, China
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053, China
You'anmen Hospital
Beijing, Beijing Municipality, 100069, China
The Ninth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100700, China
The 940th Hospital of Joint Logistics Support Force of Chinese PLA
Lanzhou, Gansu, 730050, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563003, China
Tangshan People's Hospital
Tangshan, Hebei, 063000, China
The First Hospital of Hebei Medical University
Shijiazhuang, Heibei, 050031, China
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, 010017, China
The Second Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, 215004, China
The First Hospital of Jilin University
Jilin, Jilin, 130021, China
Chifeng Municipal Hospital
Chifeng, Neimenggu, 024000, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
The 960th Hospital of Joint Logistics Support Force of Chinese PLA
Jinan, Shandong, 250031, China
Liaocheng People's Hospital
Liaocheng, Shandong, 252000, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650032, China
Biospecimen
Blood and gastric juice
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 12, 2025
First Posted
February 27, 2025
Study Start
March 1, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
March 31, 2027
Last Updated
February 27, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available upon reasonable request from 6 months after study completion to 3 years post-publication.
- Access Criteria
- Access will be granted to qualified researchers upon reasonable request through a formal data-sharing agreement.
De-identified individual participant data (IPD) will be shared. Available data includes demographic information, clinical characteristics, laboratory results, and outcome measures.