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

This study has been completed.
University of Copenhagen
Fresenius Kabi
The European Society for Clinical Nutrition and Metabolism (ESPEN)
Information provided by (Responsible Party):
Matilde Jo Allingstrup, Rigshospitalet, Denmark Identifier:
First received: June 6, 2011
Last updated: January 4, 2017
Last verified: January 2017

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.

Condition Intervention Phase
Critical Illness
Intensive Care (ICU) Myopathy
Muscle Wasting
Loss of Physical Function
Mechanical Ventilation
Other: Early Goal-Directed Nutrition
Other: ASPEN-guidelines
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Early Goal-Directed Nutrition in ICU Patients - EAT-ICU Trial

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Physical function [ Time Frame: 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

Secondary Outcome Measures:
  • Mortality [ Time Frame: 28 days ]
  • Mortality [ Time Frame: 90 days ]
  • Mortality [ Time Frame: 6 months ]
  • Survival status for all patients [ Time Frame: 6 months ]
  • New organ failure in the ICU [ Time Frame: Followed until ICU discharge, an expected average of 21 days ]
    SOFA score above 3 in every category ex. Glasgow Coma Scale Score

  • Metabolic control [ Time Frame: Followed until ICU discharge, an expected average of 21 days ]
    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)

  • New onset of renal replacement therapy [ Time Frame: Followed until ICU discharge, an expected average of 21 days ]
  • Accumulated energy- and protein balance [ Time Frame: Followed until ICU discharge, an expected average of 21 days ]
  • Length of stay in ICU [ Time Frame: Up to 52 weeks ]
    Among survivors

  • Length of stay in hospital [ Time Frame: Up to 52 weeks ]
    Among survivors

  • Serious adverse reactions in ICU [ Time Frame: Up to 52 weeks ]
    Severe allergic reactions or elevated levels of liver enzymes in plasma

  • Health related quality of life [ Time Frame: 6 months after randomisation ]
    Assessed by SF-36 questionnaire

  • Rate of nosocomial infections [ Time Frame: Followed until ICU discharge, an expected average of 21 days ]
    Defined in six subcategories by a person blinded for the intervention

  • Percent days alive without inotropic/vasopressor support at day 90 [ Time Frame: Up to 90 days ]
  • Percent days alive without renal replacement therapy at day 90 [ Time Frame: Up to 90 days ]
  • Percent days alive without mechanical ventilation at day 90 [ Time Frame: Up to 90 days ]
  • Cost analyses [ Time Frame: Up to 52 weeks ]

Enrollment: 203
Study Start Date: June 2013
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early Goal-Directed Nutrition Other: Early Goal-Directed Nutrition
  1. Initiation of early supplementary parenteral nutrition (≤ 24 hours of admission).
  2. Measurement of requirements (indirect calorimetry, 24-hour urinary urea) leading to patient-specific, individualised and goal-directed nutritional therapy.
  3. Intervention goal: delivering 100% of patient-specific requirements, measured or calculated throughout entire admission (EN+PN).
Active Comparator: ASPEN-guidelines Other: ASPEN-guidelines
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01372176

Department of Intensive Care, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
University of Copenhagen
Fresenius Kabi
The European Society for Clinical Nutrition and Metabolism (ESPEN)
Principal Investigator: Anders Perner, Professor, MD, PhD Rigshospitalet, Department of Intensive Care
Study Director: Matilde Jo Allingstrup, PhD Fellow, MSc Rigshospitalet, Department of Intensive Care
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Matilde Jo Allingstrup, PhD Fellow, MSc Clinical Nutrition, Rigshospitalet, Denmark Identifier: NCT01372176     History of Changes
Other Study ID Numbers: 2011-002547-94
Study First Received: June 6, 2011
Last Updated: January 4, 2017

Keywords provided by Rigshospitalet, Denmark:
Intensive care unit
Critical illness
Reduced quality of life
Loss of lean body mass
Loss of physical function
Optimised nutritional support
Early initiation of nutrition
Indirect calorimetry

Additional relevant MeSH terms:
Critical Illness
Muscular Atrophy
Disease Attributes
Pathologic Processes
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathological Conditions, Anatomical
Signs and Symptoms processed this record on May 22, 2017