Early Goal-Directed Nutrition in ICU Patients - EAT-ICU Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 2
- 主要终点
- Physical function
研究概览
简要总结
An increasing number of patients survive critical illness and intensive care, but describe having impaired physical function several years after discharge as a consequence of extensive loss of muscle mass. Reasons for loss of muscle mass and physical function are multiple, but insufficient nutrition is likely to contribute.
This randomised trial will investigate the effect of an optimised nutrition therapy during intensive care, on short term clinical outcome and physical quality of life. We hypothesise, that early nutritional therapy, directed towards patient-specific goals for energy and protein requirements, will improve both short- and long-term outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
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
- •Acutely admitted to the ICU
- •Expected length of stay in ICU > 3 days
- •Mechanically ventilated, which enables indirect calorimetry
- •Have central venous catheter wherein TPN can be administered
- •Written proxy consent obtained (proxy consent defined as consent from two doctors, who are independent of the trial)
- •Must be able to understand Danish
排除标准
- •Contraindications to use enteral nutrition
- •Contraindications to use parenteral nutrition, eg. hypersensitivity towards fish-, egg or peanut protein, or any of the active substances in the PN products
- •Receiving a special diet
- •Burns > 10% total body surface area
- •Severe hepatic failure (Child-Pugh class C) or severe hepatic dysfunction: Bilirubin ≥ 50 µmol/l (3 mg/dl) + alanine aminotransferase ≥ 3 times upper reference value
- •Traumatic brain injury
- •Diabetic ketoacidosis
- •Hyperosmolar non-ketotic acidosis
- •Known or suspected hyperlipidemia
- •BMI below 17 or severe malnutrition
- •Pregnancy
- •The clinician finds that the patient is too deranged (circulation, respiration, electrolytes etc.) or that death is imminent
结局指标
主要结局
Physical function
时间窗: 6 months after randomisation
Physical function 6 months after randomisation (physical component summary (PCS)-score of SF-36, conducted as phone-interview by a person blinded to the intervention
次要结局
- Length of stay in ICU(Up to 52 weeks)
- Length of stay in hospital(Up to 52 weeks)
- Health related quality of life(6 months after randomisation)
- New organ failure in the ICU(Followed until ICU discharge, an expected average of 21 days)
- Serious adverse reactions in ICU(Up to 52 weeks)
- Rate of nosocomial infections(Followed until ICU discharge, an expected average of 21 days)
- Mortality(6 months)
- New onset of renal replacement therapy(Followed until ICU discharge, an expected average of 21 days)
- Accumulated energy- and protein balance(Followed until ICU discharge, an expected average of 21 days)
- Survival status for all patients(6 months)
- Metabolic control(Followed until ICU discharge, an expected average of 21 days)
- Percent days alive without inotropic/vasopressor support at day 90(Up to 90 days)
- Percent days alive without renal replacement therapy at day 90(Up to 90 days)
- Cost analyses(Up to 52 weeks)
- Percent days alive without mechanical ventilation at day 90(Up to 90 days)
研究者
Matilde Jo Allingstrup
PhD Fellow, MSc Clinical Nutrition
Rigshospitalet, Denmark