Inflammatory and Metabolic Prognostic Assessment in Critically Ill Neurological Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorYan Zhang
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,185 Participants
are grouped into 5 trial groupsGroup A: mild Inflammation & Metabolic dysfunction
Group B: Moderate Inflammation & Metabolic Dysregulation
Group C: High Inflammation & Severe Metabolic Dysregulation
Group D: Peptide-Based Nutrition
Group E: Whole Protein Nutrition
Trial outcomes
Primary outcomes
1
All-cause mortality at Day 28 of enteral nutrition therapy
Time frame
From enrollment to 28 days after the initiation of enteral nutritionSecondary outcomes
1
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 nutrition2
Adverse outcome rate at Day 90 (defined as a Modified Rankin Scale score ≥ 3)
Time frame
At Day 90 after the initiation of enteral nutrition3
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 nutrition4
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 nutritionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yan Zhang
Lead sponsor
Xuanwu Hospital, Beijing
Sponsor institution
Source ClinicalTrials.gov
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