The Effect of a 6-month DiEtitian-TAILored Nutrition Intervention Compared to Usual Care in Patients With Critical Illness. A Single Center Prospective Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Mean energy intake
研究概览
简要总结
This research project aims to study the effect of optimal and individualised nutrition to patients with critical illness during the intensive care unit (ICU) and hospital admission, and until six months after admission. The investigators want to describe and compare the usual care with a dietitian-tailored nutrition care. The hypothesis is that dietitian-tailored nutrition care will result in a higher mean energy intake compared to usual care.
详细描述
The study will recruit patients with critical illness in one of two groups. Group one will receive standard nutrition care following the current local guidelines. Group two will receive frequent follow-up by a clinical dietitian from inclusion and until six months from admission. The dietitian will be responsible for the nutrition administered to the patient during hospital admission and will have consultations with the patients after discharge. The patients in group two will receive individualized nutrition care and recommendations.
In addition to outcome measures regarding nutrition, the patients can choose if they want to perform physical tests and blood tests as well, but that part of the study is optional. In both groups, outcome measures will be collected at day ten, 30, 90 and 180 days after admission to the ICU. The collection of data will occur even though the patients have been discharged from the hospital, either to their home or another health care facility.
The aim is to study the effect of optimal and individualised nutrition to patients with critical illness during the ICU and hospital admission, and until six months after admission. Firstly, the investigators want to describe the usual care and progression of the patients during the first six months after hospital admission. Secondly, the investigators want to see if frequent follow-up by a clinical dietitian can increase nutritional intake during the same period.
The hypothesis is that dietitian-tailored nutrition care will result in a higher mean energy intake compared to usual care, and that this will further impact other aspects, such as quality of life and physical function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Patients in intensive care who gives an informed consent and meet all of the following will be eligible:
- •Admitted to the intensive care unit for >48 hours.
- •At least 18 years of age
- •Have one or more organ system failure (respiratory,cardiovascular or renal) related to their acute illness defined as:
- •a. PaO2/FiO2≤300 mm Hg) b. Currently on one or more continuous inotrope/vasopressor infusion which were started at least 4 hours ago at a minimum dose of: i. Norepinephrine≥0.1 mcg/kg/min ii. Epinephrine≥0.1 mcg/kg/min iii. Any dose of vasopressin iv. Milrinone>0.1 mcg/kg/min) c. Renal dysfunction defined as: i. Serum creatinine 2.0-2.9 times baseline or ii. Urine output 0.5 mL/kg/hour for ≥12 hours or iii. Currently receiving renal replacement therapy) d. Currently has an intracranial pressure monitor or ventricular drain in situ
- •Permanent living address in Norway
排除标准
- •Patients will be excluded if:
- •Death is imminent in the next 96 hours or there is a current treatment limitation in place or the patient is unlikely to survive to 180 days due to underlying/chronic illness
- •Dialysis dependent chronic renal failure
- •Suspected or known pregnancy
- •Wheelchair user
- •Cognitive impairment in which intervention is considered not appropriate
- •Eating disorders -
研究组 & 干预措施
Standard care
Nutrition intervention
A 6-month Dietitian-tailored nutrition intervention
干预措施: Nutrition intervention (Other)
结局指标
主要结局
Mean energy intake
时间窗: Up to 6 months
Mean energy intake from day 10 to the end of follow-up of 6 months.
次要结局
- Protein intake(Up to 6 months)
- Nutrition intake(Day 10, day 30, day 90 and day 180)
- Nutrition risk during overall follow-up(Baseline, day 10, day 30, day 90 and day 180)
- Nutrition risk during ICU admission(ICU admission up to 6 months)
- Health related quality of life(Day 10, day 30, day 90 and day 180)
- Self-rated health state(Day 10, day 30, day 90 and day 180)
- Frailty(Baseline, day 10, day 30, day 90 and day 180)
- Mobility(ICU admission up to 6 months)
- Weight(Baseline, day 10, day 30, day 90 and day 180)
- Physical performance(Day 10, day 30, day 90 and day 180)
- Hand grip strength(Day 10, day 30, day 90 and day 180)
- Body composition(Day 10, day 30, day 90 and day 180)
- Muscle mass(Baseline, day 10, day 30, day 90 and day 180)
- Resting energy expenditure(Day 10, day 30, day 90 and day 180)
研究者
Anders Benjamin Kildal
Senior Consultant in Anesthesiology and Intensive Care
University Hospital of North Norway