Does Intermittent Nutrition Enterally Normalise Hormonal and Metabolic Responses to Feeding in Critically Ill Adults: The DINE-Normal Proof-of-concept Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Insulin
研究概览
简要总结
Overarching hypothesis In critically ill adults enteral feeding in a diurnal intermittent pattern improves patient centred outcomes.
Research questions for this study Are the same derangements in metabolic and hormonal function observed in healthy volunteers when fed continuously via a nasogastric tube observed in critically ill patients and can those derangements be mitigated by intermittent diurnal feeding?
Aim of this study Assess the effect of an enteral nutrition regimen mimicking the usual diurnal meal pattern on hormonal profile and metabolism in critically ill adults. This will generate novel and important proof of concept data and support progression to a clinical trial integrating investigation of physiological responses and patient centred outcomes.
Objectives of this study Laboratory: Characterise patterns of hormone, lipid and metabolite response to intermittent diurnal feeding in critically ill adults.
Clinical: assess feasibility, tolerability (vomiting and gastric residual volume) and efficacy (calorie delivery) of intermittent diurnal feeding in critically ill adults.
详细描述
Setting Single adult general intensive care unit in Bristol with 48 beds and ~2500 admissions annually
Design Parallel group randomised, open-label trial
Population We will recruit from a representative critically ill population and exclude patients with conditions that pose undue risk and/or introduce bias.
See eligibility criteria.
Screening and recruitment Usual care team will screen daily. Eligibility will be confirmed by health care professional on the delegation log and recorded in the ICU clinical information system. This may be done remotely. A screening log will be kept.
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
- 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
- •Adults (≥18) on intensive care
- •Planned for gastric enteral nutrition (anticipated duration >48 hours)
排除标准
- •>24 hours after commencement of enteral nutrition
- •Gastrointestinal surgery or pathology
- •Diabetic emergencies
- •Pregnancy
- •Parenteral or jejunal nutrition
- •Trophic feed only
- •Prone positioning
- •High risk of refeeding syndrome
结局指标
主要结局
Insulin
时间窗: Peak within 3 hours of bolus feed (comparable time point in comparator)
Plasma insulin and C-Peptide
次要结局
- Urea(Study day 1 and study day 2)
- Glycerol(Study day 1 and study day 2)
- Glucagon-like peptide 1(Study day 1 and study day 2)
- Ketones(Study day 1 and study day 2)
- Non-esterified fatty acids(Study day 1 and study day 2)
- Triglyceride(Study day 1 and study day 2)
- Calories delivered(Study day 1 and study day 2)
- Incidence of gastrointestinal upset (GI upset)(Study day 1 and study day 2)
- Mortality(ICU and acute hospital)
- Length of stay(ICU and acute hospital)
- Delta-SOFA(Day 0 and day 2)
- Compliance(Study day 1 and study day 2)
研究者
Matt Thomas
Consultant in Intensive Care Medicine
North Bristol NHS Trust