The Effect of Enriched Enteral Nutrition on Inflammation and Sub-clinical Organ Dysfunction During Human Endotoxemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- circulating cytokines
研究概览
简要总结
During sepsis and septic shock the immune response can be overwhelming leading to excessive tissue damage, organ failure and death. Ideally, the inflammatory response is modulated leading to both adequate protection to invading pathogens as well as limitation of an exuberant immune response. In the last years, experimental evidence has been accumulating that enteral administration of lipid-enriched nutrition attenuates inflammation and preserves organ integrity in several inflammatory models. The current study investigates the immune-modulating potential of enriched enteral nutrition in a human setting of experimental endotoxemia.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 and ≤ 35 yrs
- •Written informed consent
- •non-smoking
排除标准
- •Use of any medication (e.g. NSAID's, antibiotics, gastrointestinal motility altering medicine, corticosteroids)
- •Smoking in the past year
- •History, signs or symptoms of cardiovascular disease
- •(Family; first degree) history of cerebrovascular disease
- •Previous vagal collapse
- •Hypertension (defined as RR systolic > 160 or RR diastolic > 90)
- •Hypotension (defined as RR systolic < 100 or RR diastolic < 50)
- •Renal impairment (defined as plasma creatinin >120 μmol/l)
- •Liver enzyme abnormalities ( ASAT > 60 U/L, ALAT > 75 U/L, Gamma-GT > 60 U/L)
- •Positive hepatitis serology
- •Positive HIV test
- •Allergy to milk and/or soy proteins
研究组 & 干预措施
fasted control
Volunteers are fasted for 10 hours and subjected to experimental endotoxemia
control feeding
Volunteers are fed a control nutrition starting 1 hour prior to LPS administration until 6 hours after LPS
干预措施: control enteral nutrition (Other)
enriched feeding
volunteers receive the investigational feeding starting 1 hour prior to LPS administration until 6 hours after LPS
干预措施: enriched enteral feeding (Other)
结局指标
主要结局
circulating cytokines
时间窗: several time points from LPS administration until 24 hours
次要结局
- markers for sub-clinical organ damage (kidney, endothelium, intestine)(several time points from LPS administration until 24 h)