Comparison of Short Peptide and Whole Protein Formula in the Early Enteral Nutrition of Patients With Sepsis: a Single-Center, Prospective, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Metabolomics changes form
研究概览
简要总结
To explore the effects of early enteral nutrition with short peptide formula on energy metabolism and clinical outcomes in patients with sepsis based on blood samples, clinical database, full-spectrum metabolomics test and imaging data, and to form a theoretical basis for optimizing the formula of early enteral nutrition in patients with sepsis.
详细描述
This study is a single-center prospective trial. Based on the annual patient volume, available human resources, and funding at our research center, the expert team determined a sample size of 80 cases, with 40 cases in the experimental group and 40 in the control group. Eligible participants will be randomized 1:1 via computer-generated randomization into two groups, receiving either a short-peptide-based enteral nutrition formula or a whole-protein-based enteral nutrition formula.
Short-peptide formula group:
Within 48 hours of ICU admission, short-peptide-based enteral nutrition (Peptisorb) will be initiated. For patients with impaired swallowing or unconsciousness, a nasogastric tube will be placed. Feeding will start with low-calorie or trophic feeding, reaching 70% of the target energy and 1.2-1.5 g/kg/day of protein within 7 days. Due to significant individual variability in energy expenditure among sepsis patients, indirect calorimetry (IC) will be used to measure energy needs. If IC is unavailable, a weight-based formula (20-25 kcal/kg/day) will be applied. If patients remain in the ICU after 7 days, feeding will be gradually increased to full energy and protein targets as tolerated, followed by a transition to whole-protein nutrition.
Whole-protein formula group:
Within 48 hours of ICU admission, whole-protein-based enteral nutrition (Nutrison) will be initiated, with the remaining protocol identical to the short-peptide group.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent has been signed
- •Aged from 18 to 80 years old
- •Within 24 hours after admission to ICU
- •Sepsis was diagnosed according to the 2016 International Sepsis 3.0 diagnostic criteria
- •Without gastrointestinal perforation, bleeding, obstruction and other contraindications to enteral nutrition
- •Expected ICU stay for more than 7 days
排除标准
- •Receiving palliative care or expected to die within 72 hours
- •Pregnant or breastfeeding
- •Use of high dose vasopressor maintenance (norepinephrine dosage > 0.5 μg/kg/min)
- •Requiring restricted protein intake or additional protein supplementation (e.g., patients with hepatic encephalopathy, severe renal insufficiency, severe burns, severe malnutrition, etc..)
研究组 & 干预措施
Short peptide formula
Within 48 hours of ICU admission, short-peptide-based enteral nutrition (Peptisorb) will be initiated. For patients with impaired swallowing or unconsciousness, a nasogastric tube will be placed. Feeding will start with low-calorie or trophic feeding, reaching 70% of the target energy and 1.2-1.5 g/kg/day of protein within 7 days. Due to significant individual variability in energy expenditure among sepsis patients, indirect calorimetry (IC) will be used to measure energy needs. If IC is unavailable, a weight-based formula (20-25 kcal/kg/day) will be applied. If patients remain in the ICU after 7 days, feeding will be gradually increased to full energy and protein targets as tolerated, followed by a transition to whole-protein nutrition.
干预措施: Short peptide enteral nutrition (Dietary Supplement)
Whole protein formula
Within 48 hours of ICU admission, whole-protein-based enteral nutrition (Nutrison) will be initiated, with the remaining protocol identical to the short-peptide group.
干预措施: Whole protein enteral nutrition (Dietary Supplement)
结局指标
主要结局
Metabolomics changes form
时间窗: On the 7th day after enrollment
Key assessments include: ① Concentration changes of differential metabolites in core pathways (BCAA, SCFA, bile acid metabolism); ② Correlation between metabolite fluctuations and nutritional markers (albumin, prealbumin); ③ Predictive modeling linking metabolic signatures to clinical outcomes (infection rate, ICU LOS). The above data were all normalized and ultimately presented in the form of a heatmap.
次要结局
- Days of ventilator use(28 days)
- Daily average protein intake(7 days)
- Daily average energy intake(7 days)
- Energy adequacy rate(On the 3rd and 7th day after enrollment)
- Inflammatory markers(7 days)
- Nutritional status(7 days)
- Liver function(7 days)
- Renal function(7 days)
- Enteral nutritional tolerance rate(7 days)
- Skeletal muscle depletion condition(7 days)
- 28-day all-cause mortality rate(28 days)
- All-cause mortality at 90 days(90 days)
研究者
Ming Zhong
Doctor
Shanghai Zhongshan Hospital