The Effect of Semi-elemental Enteral Nutrition on Gastrointestinal Tolerance in Patients With Traumatic Brain Injury: a Randomized Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of Gastrointestinal Intolerance
研究概览
简要总结
Study Objective This clinical trial primarily aims to investigate whether semi-elemental enteral nutrition (SEN) improves gastrointestinal tolerance in patients with severe traumatic brain injury (TBI) and to evaluate its impact on clinical outcomes. The safety profile of SEN will also be assessed.
Key Research Questions Does SEN reduce the incidence of acute gastrointestinal injury (AGI) in severe TBI patients?
Study Design
Participants will be randomized 1:1 into either:
Intervention group: Receives SEN initiated within 48 hours post-injury and continued for ≥7 days.
Control group: Receives standard enteral nutrition over the same period.
详细描述
Background:
Patients with traumatic brain injury (TBI) frequently exhibit gastrointestinal dysfunction secondary to central nervous system impairment. This dysregulation impairs nutrient absorption, exacerbates systemic inflammation, and compromises clinical recovery trajectories. Emerging evidence suggests that semi-elemental enteral nutrition (SEN)-featuring hydrolyzed macronutrients with low-osmolality formulations-may mitigate these sequelae by reducing digestive burden and enhancing mucosal healing. However, robust clinical evidence supporting its superiority over standard enteral feeding in severe TBI populations remains limited.
Objectives:
Primary Objective:
To evaluate the efficacy of semi-elemental enteral nutrition (SEN) in improving gastrointestinal tolerance during the acute phase (first 7 days post-injury) in patients with severe traumatic brain injury (TBI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years;
- •Clinically diagnosed with closed traumatic brain injury;
- •Glasgow Coma Scale (GCS) score ≤ 8;
- •Ability to initiate enteral nutrition within 48 hours post-injury;
- •Expected need for enteral nutrition support ≥3 days based on clinical assessment (Nutritional Risk Screening 2002 [NRS2002] score ≥3).
排除标准
- •GCS=3 with bilateral fixed and dilated pupils;
- •Hemodynamic instability or respiratory failure: mean arterial pressure <70mmHg, PaO2/FiO2<150, PaCO2<30 mmHg or >45 mmHg, or lactate >5 mmol/l;
- •Contraindications to both nasogastric and nasojejunal tube placement, or inability to complete tube placement within 48 hours of onset;
- •Contraindications to enteral nutrition therapy or semi-recumbent positioning;
- •Pre-existing intellectual disability or physical disability affecting outcome assessment;
- •Gastrointestinal abnormalities likely to affect gastrointestinal function, such as short bowel syndrome (defined as total small bowel length ≤122 cm), ulcerative colitis, Crohn's disease, or any form of ostomy;
- •Body mass index (BMI) <18kg/m2;
- •Concomitant abdominal injury or extracranial injury with AIS score >3 in any region;
- •Presence of malignancy, severe cardiac insufficiency (ejection fraction <50%), severe hepatic failure (Child-Pugh score ≥7), or severe renal failure (glomerular filtration rate ≤30 mL/min or serum creatinine ≥4mg/dL) at NICU admission;
- •Concurrent severe disease with expected survival ≤14 days;
- •Pregnancy, within 30 days postpartum, or breastfeeding;
- •Refusal of treatment or receipt of palliative care;
- •Patient or family declines informed consent;
- •Current participation in another interventional clinical trial.
研究组 & 干预措施
Intervention Group
Patients will receive semi-elemental enteral nutrition.
干预措施: Semi-elemental formula (Dietary Supplement)
Control Group
Patients will receive standard enteral nutrition.
干预措施: Standard formula (Dietary Supplement)
结局指标
主要结局
Incidence of Gastrointestinal Intolerance
时间窗: Within 7 days.
Proportion of patients developing gastrointestinal intolerance within 7 days of enteral nutrition initiation. (Composite endpoint including: vomiting, diarrhea, constipation, gastroparesis, gastrointestinal bleeding, and abdominal distension.)
次要结局
- Six-month mortality(Within 6 months.)
- ICU mortality(Periprocedural)
- Hospitalization length of stay (LOS)(Periprocedural.)
- NICU LOS(Periprocedural)
- Three-month mortality(Within 3 months.)
- In-hospital mortality(Periprocedural.)
- Functional outcomes (Barthel)(Within 6 months.)
- Gastrointestinal intolerance events(Within 7 days.)
- Infection(Within 14 days)
- Functional outcomes (GOSE)(Within 6 months.)