Stroke AcuteIMPACT-NEURONCT06849011
Inflammatory and Metabolic Prognostic Assessment in Critically Ill Neurological Patients
An observational study of Stroke Acute and Encephalitis, run by Yan Zhang at 19 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke Acute, Encephalitis, Non-traumatic Brain Injury
- How many people
- 1,185 participants
- Where
- 19 sitesChina
- Study dates
- 1 Mar 2025to 31 Mar 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
China19 sites
Beijing Hui People's Hospital
Beijing, Beijing Municipality, 100053
Yanbo He, 8618612691914, htyopen@163.com
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Yan Zhang, 8613671376710, zhangylq@sina.com
You'anmen Hospital
Beijing, Beijing Municipality, 100069
Dan Xin, 8615321688898, 1195048308@qq.com
The Ninth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100700
Juan Du, 8613901362737, juanzijuanzi@263.net
Chifeng Municipal Hospital
Chifeng, Neimenggu, 024000
Huijie Zhou, 8613948690409, 1031581493@qq.com
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002
Xiao Hu, 8618096105119, 18096105119@163.com
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, 010017
Runxiu Zhu, 8618047191885, zhurunxiu@163.com
The First Hospital of Jilin University
Jilin City, Jilin, 130021
Jie Cao, 8613756947788, cjie@jlu.edu.cn
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Qinzhou Wang, 8618560085523, qinzhouwang@163.com
The 960th Hospital of Joint Logistics Support Force of Chinese PLA
Jinan, Shandong, 250031
Huaiqiang Hu, 8613156189722, huhuaiqiang@126.com
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650032
Lei Zhang, 8613759176858, 845585258@qq.com
The 940th Hospital of Joint Logistics Support Force of Chinese PLA
Lanzhou, Gansu, 730050
Xiaoyan Zhang, 8613919931411, zhangxiaoyan060110@163.com
Liaocheng People's Hospital
Liaocheng, Shandong, 252000
Dong Guo, 8613396258699, guodonglc@126.com
The First Hospital of Hebei Medical University
Shijiazhuang, Heibei, 050031
Jia Tian, 8615097392050, 15097392050@163.com
The Second Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, 215004
Jijun Shi, 8615895551663, shijijun2008@126.com
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Liansheng Ma, 8615935111597, zly4200@sina.com
Tangshan People's Hospital
Tangshan, Hebei, 063000
Yan Wang, 8613333299772, doctor_wy@163.com
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Tao Guo, 8613895092758, zfgt1@163.com
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563003
Zucai Xu, 8613368663217, docxzc@126.com
About this study
Official title: Development and Validation of a Prognostic Prediction Model for Adverse Outcomes in Neurocritical Patients Receiving Enteral Nutrition Based on Key Inflammatory and Metabolic Markers
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.
Read the detailed description
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
- Stroke Acute, Encephalitis, Non-traumatic Brain Injury
- Keywords
- enteral nutrition, adverse prognosis, prediction model, non-traumatic severe brain injury
- Medical subject headings
- Stroke, Encephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality at Day 28 of enteral nutrition therapy
Measured: 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)
Measured: At Day 3 after the initiation of enteral nutrition
Adverse outcome rate at Day 90 (defined as a Modified Rankin Scale score ≥ 3)
Measured: 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)
Measured: Within 14 days after the initiation of enteral nutrition
Gastrointestinal intolerance within 14 days (gastric residual volume > 200 mL, nausea, vomiting, bloating, diarrhea)
The gastric residual volume is assessed every 4 hours by the nurse through aspiration via the nasogastric tube. Other clinical manifestations such as nausea, vomiting, bloating, and diarrhea are assessed through daily observation by the attending physician.
Measured: 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)
Measured: Within 14 days after the initiation of enteral nutrition
Number of days with random blood glucose > 10 mmol/L within 14 days
Measured: Within 14 days after the initiation of enteral nutrition
Average daily insulin requirement within 14 days
Measured: Within 14 days after the initiation of enteral nutrition
Incidence of hypophosphatemia within 3 days
Measured: Within 3 days after the initiation of enteral nutrition
Duration of mechanical ventilation within 14 days
Measured: Within 14 days after the initiation of enteral nutrition
Length of NICU stay
Measured: From enrollment to discharge from the NICU, up to 1 year.
Total hospital stay duration
Measured: From enrollment to discharge, up to 1 year.
90-day readmission rate post-discharge
Measured: Within 90 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yan Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yan Zhang, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849011
- Sponsor's protocol ID
- xwzc202500102
- Acronym
- IMPACT-NEURO
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared. Available data includes demographic information, clinical characteristics, laboratory results, and outcome measures.