Randomized Controlled Trial of Hypocaloric Hyperproteic Enteral Nutrition in the Critically Ill Patient
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in the intial SOFA (Sequential Organ Failure Assessment) score at 48 hours.
研究概览
简要总结
The aim of this study is to compare two nutritional regimes in critically ill patients. Patients will be randomized to standard care (25 kcal per kg) or to hypocaloric nutrition (15 kcal per kg). Both regimes will recive 1,7 g/Kg/dia The main outcome will be the SOFA (sequential organ failure assessment) score. The hypothesis is that hypocaloric hyperproteic diet decreases the incidence of organic failure in these patients.
详细描述
The research site will be the intensive care unit (ICU) of Hospital Universitario San Ignacio; eligible patients will >18 years of age with a presumed fasting period of at least 96 hours, with no contraindications for enteral nutrition. Patients with parenteral nutrition, pregnancy, diabetes, liver failure, renal failure, transplant protocol, or admitted from another hospital will be excluded. In all patients, the following information will be collected daily: enteral formula in ml, carbohydrate intake, insulin required (in IU), presence of hyper or hypoglicemia, presence of infections, among others.
The SOFA score will be assessed every two days until discharge from ICU.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years
- •Estimated fasting period of at least 96 hours
- •ICU patients
排除标准
- •Parenteral nutrition
- •Pregnancy
- •Liver failure
- •Transplantation or in transplant protocol
- •Previous nutrition support
- •Chronic Renal failure
结局指标
主要结局
Change in the intial SOFA (Sequential Organ Failure Assessment) score at 48 hours.
时间窗: 48 hours after the onset of nutrition
SOFA score evaluates six systems: respiratory, cardiovascular, coagulation, Central Nervous System, liver and renal. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality).
次要结局
- Number of days in the intensive care unit(Within the first 28 days after the onset of nutrition)
- Mortality to 28 days(28 days after the onset of nutrition)
- Units of insulin require in a day(Within the first 4 days after the onset of nutrition)
- Number of days the patient requires mechanical ventilation.(Within the first 28 days after the onset of nutrition)