Impact of Early Enteral vs. Parenteral Nutrition on Preservation of Gut Mucosa Integrity in Patients Requiring Mechanical Ventilation and Catecholamines: an Ancillary Study of the NUTRIREA2 Trial (NCT01802099)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 169
- 试验地点
- 6
- 主要终点
- Plasma citrulline level
研究概览
简要总结
To demonstrate that a strategy involving early first-line enteral nutrition is associated with improved preservation of gut mucosa integrity, as assessed based on the plasma citrulline level at H72, compared to a strategy involving early first-line parenteral nutrition
详细描述
Published data suggest that enteral nutrition may be associated with improved preservation of the gut lymphoid tissues and gut immune function, as well as with decreased gut mucosa permeability, thereby diminishing the risk of organ failure. Citrulline is an amino acid produced from glutamine by small-bowel enterocytes. Plasma citrulline levels reflect functional enterocyte mass. Intestinal fatty acid-binding protein (I-FABP, also known as FABP2) is a small protein found in the cytosol of small-bowel enterocytes. Plasma I-FABP is normally undetectable and, when elevated, constitutes a reliable marker for enterocyte damage. The hypothesis underlying this ancillary study is that first-line enteral nutrition is associated with improved gut mucosa integrity and function compared to parenteral nutrition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Invasive mechanical ventilation expected to be required more than 48 hours
- •Nutrition started within 24 hours after initiation of endotracheal mechanical ventilation
- •Treatment with vasoactive drug administered via a central venous catheter
- •Age over 18 years
- •Signed information
排除标准
- •Abdominal surgery within 1 month before inclusion
- •History of esophageal, gastric, duodenal or pancreatic surgery
- •Bleeding from the esophagus, stomach or bowel
- •enteral nutrition via gastrostomy or jejunostomy
- •pregnancy
- •Treatment-limitation decisions
- •Current inclusion in a trial on comparison between enteral and parenteral nutrition
研究组 & 干预措施
Parenteral nutrition
Patients will receive parenteral nutrition during the first week of mechanical ventilation. After Day 3, the parenteral route may be switched to the enteral route if shock resolve (vasoactive drug stopped since 24 hours and serum lactate level < 2 mmol/l). After Day 7, all patients will be fed via the enteral route.
干预措施: Parenteral nutrition (Other)
Enteral nutrition
Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation.
干预措施: Enteral Nutrition (Other)
结局指标
主要结局
Plasma citrulline level
时间窗: 72 hours
次要结局
- proportion of patients whose plasma I-FABP is ≥100 pg/mL(Day 0, Day 3, Day 8)
- mean plasma citrulline(Day 0, Day 3, Day 8)
- SOFA score(first week)
- plasma levels of citrulline(Day 0, Day 3, Day 8)
- I-FABP(Day 0, Day 3, Day 8)
- proportion of patients whose plasma citrulline is ≤10 μL/L(Day 0, Day 3, Day 8)
- mean plasma I-FABP(Day 0, Day 3, Day 8)
- proportion of patients with at least one episode of bacteremia(until discharge from ICU (average: 10 days))
- proportion of patients with at least one episode of gastrointestinal intolerance(until discharge from ICU (average: 10 days))
- proportion of patients with at least one episode of diarrhea(until discharge from ICU (average: 10 days))