Appropriate Controlled Feeding: a Single Blinded Prospective Randomised Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Septic complication
研究概览
简要总结
During patients' stay in the hospital, some of the patients may require artificial feeding for various reasons either through a vein or through a tube going directly to the gut. However, the amount of feeding that can be considered 'adequate' is unclear due to lack of research data. The current evidence the investigators have suggests that doctors might be giving patients more than they require, which might carry some risks. This hasn't been proven until now and there is no evidence as yet to show investigators exactly how much the doctors should feed patients.
The aim of the study is to see whether feeding patients less than what they are currently been feed is associated with better outcome.
The patients will be randomly (like tossing a coin) allocated into 2 groups. One group will get 100% of the current amount; the second group will get 60%. The investigators will then compare the groups to decide if feeding patients less than the current practice is associated with better outcomes.
详细描述
Aims:
The primary aim of this study is to assess whether hypocaloric feeding in patients receiving artificial nutritional support is associated with reduced septic and non septic morbidity compared to "standard" nutritional support. Secondary end points will include the assessment of metabolic, physiological and clinical responses to the different feeding protocols.
ENTERAL FEEDING OBJECTIVES
- To investigate whether or not hypocaloric feeding in patients receiving enteral artificial nutritional support is associated with reduced septic and non septic morbidity compared to "standard" nutritional support.
- To investigate whether or not hypocaloric feeding in patients receiving enteral artificial nutritional support is associated with changes in the inflammatory response compared to "standard" nutritional support.
- To investigate whether or not hypocaloric feeding in patients receiving enteral artificial nutritional support is associated with changes in metabolic response compared to "standard" nutritional support.
- To investigate whether or not hypocaloric feeding in patients receiving enteral artificial nutritional support is associated with changes in nutrition status compared to "standard" nutritional support.
- To investigate whether or not hypocaloric feeding in patients receiving enteral artificial nutritional support is associated with differences in systemic complications compared to "standard" nutritional support.
- To undertake a cost benefit analysis in patients receiving enteral artificial nutritional support, with the assumption that patients receiving hypocaloric feeding will not necessarily manifest lower feeding costs.
PARENTERAL FEEDING OBJECTIVES
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •All patients requiring artificial nutritional support in the hospital
排除标准
- •Failure to obtain informed consent / assent from next of kin.
- •Patients at risk of refeeding syndrome.
- •If patients require concomitant enteral and parenteral nutrition.
- •Pregnant women and children under the age of 18 years.
研究组 & 干预措施
Normocaloric feeding
This control group will receive energy and protein intakes as recommended by the use of Schofield equations, as is current practice (100% of requirements)
干预措施: Hypocaloric feeding (Other)
结局指标
主要结局
Septic complication
时间窗: average of one week
次要结局
- Inflammatory response(average of one week)
- Metabolic response(average of one week)
- Nutrition status(average of one week)
- Systematic complications(average of one week)
- Cost benefit analysis(average of one week)
研究者
Anwar Owais
Mr
Scarborough General Hospital