Early Goal-Directed Nutrition in ICU Patients - EAT-ICU Trial

Study Overview
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Brief Summary
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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.

Official Title
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Early Goal-Directed Nutrition in ICU Patients - EAT-ICU Trial

Conditions
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Critical Illness, Intensive Care (ICU) Myopathy, Muscle Wasting, Loss of Physical Function, Mechanical Ventilation

Intervention / Treatment
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* Other: Early Goal-Directed Nutrition
* Other: ASPEN-guidelines


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Goal-Directed Nutrition<br> | Other: Early Goal-Directed Nutrition<br>* Initiation of early supplementary parenteral nutrition (≤ 24 hours of admission). Measurement of requirements (indirect calorimetry, 24-hour urinary urea) leading to patient-specific, individualised and goal-directed nutritional therapy. Intervention goal: delivering 100% of patient-specific requirements, measured or calculated throughout entire admission (EN+PN).<br>|
| Active Comparator: ASPEN-guidelines<br> | Other: ASPEN-guidelines<br>* EN will be the preferred route of nutrition, and will be initiated within the first 24 hours of ICU admission, in accordance with best evidence. The amount is gradually increased over the first days of admission as tolerated by the patient (assessed from gastric aspirates). If EN fails to reach calculated goals at day 7, supplementary PN will be initiated at admission day 8 to reach goals. Protein and energy goals will be calculated as 25 kcal/kg/day and 1.2 g protein/kg/day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function | 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 | 6 months after randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 28 days | 
| Mortality |  | 90 days | 
| Mortality |  | 6 months | 
| Survival status for all patients |  | 6 months | 
| New organ failure in the ICU | SOFA score above 3 in every category ex. Glasgow Coma Scale Score | Followed until ICU discharge, an expected average of 21 days | 
| Metabolic control | Accumulated insulin administration to maintain B-glucose ≤10 mmol/l and rates of severe hyper- and hypoglycaemia (B-glucose >15 mmol/l or ≤2.2 mmol/l, respectively) | Followed until ICU discharge, an expected average of 21 days | 
| 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 | 
| Length of stay in ICU | Among survivors | Up to 52 weeks | 
| Length of stay in hospital | Among survivors | Up to 52 weeks | 
| Serious adverse reactions in ICU | Severe allergic reactions or elevated levels of liver enzymes in plasma | Up to 52 weeks | 
| Health related quality of life | Assessed by SF-36 questionnaire | 6 months after randomisation | 
| Rate of nosocomial infections | Defined in six subcategories by a person blinded for the intervention | 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 | 
| Percent days alive without mechanical ventilation at day 90 |  | Up to 90 days | 
| Cost analyses |  | Up to 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive care unit, Critical illness, Mortality, Reduced quality of life, Loss of lean body mass, Loss of physical function, Optimised nutritional support, Early initiation of nutrition, Indirect calorimetry