An observational study in Stroke Acute, Encephalitis and Non-traumatic Brain Injury, sponsored by Yan Zhang. Not yet recruiting at 19 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-27.
Sponsored by Yan Zhang · Observational
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 1,185 is above the median of 152 across 1,968 observational studies indexed under Stroke.
Browse Stroke studies →This is the only study on the registry with Yan Zhang as lead sponsor.
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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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Select patients who received peptide-based formulas from the entire database for poor prognosis analysis.
Select patients who received whole protein formulas from the database for poor prognosis analysis.
All-cause mortality at Day 28 of enteral nutrition therapy
Time frame: From enrollment to 28 days after the initiation of enteral nutrition
Nutritional goal achievement rate at Day 3 (caloric and protein intake reaching 70%-100% of calculated target)
Time frame: At Day 3 after the initiation of enteral nutrition
Adverse outcome rate at Day 90 (defined as a Modified Rankin Scale score ≥ 3)
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: Within 14 days after the initiation of enteral nutrition
Number of days with random blood glucose > 10 mmol/L within 14 days
Time frame: Within 14 days after the initiation of enteral nutrition
Average daily insulin requirement within 14 days
Time frame: Within 14 days after the initiation of enteral nutrition
Incidence of hypophosphatemia within 3 days
Time frame: Within 3 days after the initiation of enteral nutrition
Duration of mechanical ventilation within 14 days
Time frame: Within 14 days after the initiation of enteral nutrition
Length of NICU stay
Time frame: From enrollment to discharge from the NICU, up to 1 year.
Total hospital stay duration
Time frame: From enrollment to discharge, up to 1 year.
90-day readmission rate post-discharge
Time frame: Within 90 days after discharge
Plan to share: Yes — De-identified individual participant data (IPD) will be shared. Available data includes demographic information, clinical characteristics, laboratory results, and outcome measures.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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