Development and Validation of a Prognostic Prediction Model for Adverse Outcomes in Neurocritical Patients Receiving Enteral Nutrition Based on Key Inflammatory and Metabolic Markers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,185
- 试验地点
- 19
- 主要终点
- All-cause mortality at Day 28 of enteral nutrition therapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •NRS 2002 score ≥
- •Kuwata drinking test ≥ grade
- •Acute Gastrointestinal Injury (AGI) grade 1 or
- •Signed informed consent obtained from the patient or their legal representative.
排除标准
- •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.
结局指标
主要结局
All-cause mortality at Day 28 of enteral nutrition therapy
时间窗: From enrollment to 28 days after the initiation of enteral nutrition
次要结局
- 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)
- Number of days with random blood glucose > 10 mmol/L within 14 days(Within 14 days after the initiation of enteral nutrition)
- Average daily insulin requirement within 14 days(Within 14 days after the initiation of enteral nutrition)
- Incidence of hypophosphatemia within 3 days(Within 3 days after the initiation of enteral nutrition)
- Duration of mechanical ventilation within 14 days(Within 14 days after the initiation of enteral nutrition)
- Length of NICU stay(From enrollment to discharge from the NICU, up to 1 year.)
- Total hospital stay duration(From enrollment to discharge, up to 1 year.)
- 90-day readmission rate post-discharge(Within 90 days after discharge)
研究者
Yan Zhang
Professor
Xuanwu Hospital, Beijing