The Effect of an Individualized Nutrition Formula on Clinical Prognosis, Intestinal and Pulmonary Microbiota, Serum Metabolomics, and Macronutrient Balance in Critically Ill Patients: A Prospective Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,200
- 主要终点
- Length of ICU Stay
研究概览
简要总结
This study aims to evaluate the effects of an individualized enteral nutrition formula on clinical outcomes in critically ill adult patients in the intensive care unit (ICU). Participants will be randomly assigned to one of two groups: the individualized nutrition group or the standard nutrition group. In the individualized group, the total daily amount of enteral nutrition will be calculated and adjusted daily based on the patient's resting energy expenditure (measured by indirect calorimetry) and serum protein levels. In the standard group, a fixed-dose formula will be administered according to routine clinical protocols recommended by current guidelines. The intervention will be initiated within 48 hours of ICU admission and continued for up to 14 days or until ICU discharge. The study will assess clinical prognosis, as well as changes in gut and pulmonary microbiota, serum metabolomics, and macronutrient balance. The findings may provide evidence for personalized nutrition strategies in critically ill patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critically ill patients admitted to the intensive care unit (ICU) who meet the indications for enteral nutrition support.
- •Age ≥ 18 years. APACHE II score > 8 at ICU admission. Expected ICU length of stay > 7 days.
排除标准
- •Age < 18 years. Pregnancy or lactation. Known allergy to any component of the enteral nutrition formula. Gastrointestinal bleeding, incomplete intestinal obstruction, or other conditions precluding full enteral nutrition.
- •Known severe thyroid dysfunction (e.g., thyrotoxic crisis, myxedema coma, or uncontrolled hyperthyroidism/hypothyroidism).
- •Chronic end-stage organ failure, including: New York Heart Association (NYHA) Class IV heart failure, Child-Pugh Class C cirrhosis, or Stage 5 chronic kidney disease (CKD).
- •Primary intestinal diseases (e.g., Crohn's disease, ulcerative colitis, or intestinal malignancies), short bowel syndrome, or history of extensive small bowel resection (residual small intestine < 100 cm).
- •Metabolic disorders that significantly affect nutritional metabolism (e.g., Sheehan's syndrome, or other conditions with major metabolic consequences) as determined by the investigator.
结局指标
主要结局
Length of ICU Stay
时间窗: Up to 90 days
Total number of days from ICU admission to ICU discharge.
次要结局
未报告次要终点
研究者
Juanhong Shen
Nanjing Drum Tower Hospital
Chinese Medical Association