Clinical trial NCT06849011: Inflammatory and Metabolic Prognostic Assessment in Critically Ill Neurological Patients
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stroke Acute
Encephalitis
Non-traumatic Brain Injury
Keywords: enteral nutrition
adverse prognosis
prediction model
non-traumatic severe brain injury
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 1185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 80 years, no gender restrictions.
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:

1. Severe malnutrition prior to admission, defined as BMI \< 16 kg/m².
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.

Primary outcomes:
measure: All-cause mortality at Day 28 of enteral nutrition therapy
timeFrame: From enrollment to 28 days after the initiation of enteral nutrition
Secondary outcomes:
measure: Nutritional goal achievement rate at Day 3 (caloric and protein intake reaching 70%-100% of calculated target)
timeFrame: At Day 3 after the initiation of enteral nutrition
measure: Adverse outcome rate at Day 90 (defined as a Modified Rankin Scale score ≥ 3)
timeFrame: At Day 90 after the initiation of enteral nutrition
measure: Incidence of infectious complications within 14 days (including pneumonia, urinary tract infections, bloodstream infections, skin infections, and Clostridium difficile infections)
timeFrame: Within 14 days after the initiation of enteral nutrition
measure: Gastrointestinal intolerance within 14 days (gastric residual volume > 200 mL, nausea, vomiting, bloating, diarrhea)
timeFrame: Within 14 days after the initiation of enteral nutrition
measure: Incidence of gastrointestinal bleeding within 14 days (gastric occult blood, fecal occult blood, hematemesis, melena, hematochezia)
timeFrame: Within 14 days after the initiation of enteral nutrition
measure: Number of days with random blood glucose > 10 mmol/L within 14 days
timeFrame: Within 14 days after the initiation of enteral nutrition
measure: Average daily insulin requirement within 14 days
timeFrame: Within 14 days after the initiation of enteral nutrition
measure: Incidence of hypophosphatemia within 3 days
timeFrame: Within 3 days after the initiation of enteral nutrition
measure: Duration of mechanical ventilation within 14 days
timeFrame: Within 14 days after the initiation of enteral nutrition
measure: Length of NICU stay
timeFrame: From enrollment to discharge from the NICU, up to 1 year.
measure: Total hospital stay duration
timeFrame: From enrollment to discharge, up to 1 year.
measure: 90-day readmission rate post-discharge
timeFrame: Within 90 days after discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hui People's Hospital
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: You'anmen Hospital
state: Beijing
city: Beijing
country: China
facility: The Ninth Medical Center of Chinese PLA General Hospital
state: Beijing
city: Lanzhou
country: China
facility: The 940th Hospital of Joint Logistics Support Force of Chinese PLA
state: Gansu
city: Guiyang
country: China
facility: Guizhou Provincial People's Hospital
state: Guizhou
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Tangshan
country: China
facility: Tangshan People's Hospital
state: Hebei
city: ShijiaZhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Heibei
city: Hohhot
country: China
facility: Inner Mongolia Autonomous Region People's Hospital
state: Inner Mongolia
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Suzhou University
state: Jiangsu
city: Jilin
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Chifeng
country: China
facility: Chifeng Municipal Hospital
state: Neimenggu
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: The 960th Hospital of Joint Logistics Support Force of Chinese PLA
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University
state: Shanxi
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
state: Yunnan
Study officials:
References: