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

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ClinicalTrials.gov Identifier: NCT01372176
Recruitment Status : Completed
First Posted : June 13, 2011
Last Update Posted : January 5, 2017
Sponsor:
Collaborators:
University of Copenhagen
Fresenius Kabi
The European Society for Clinical Nutrition and Metabolism (ESPEN)
Information provided by (Responsible Party):
Matilde Jo Allingstrup, Rigshospitalet, Denmark

Study Description
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Brief Summary:

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 or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Early Goal-Directed Nutrition in ICU Patients - EAT-ICU Trial
Study Start Date : June 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Mortality [ Time Frame: 28 days ]
  2. Mortality [ Time Frame: 90 days ]
  3. Mortality [ Time Frame: 6 months ]
  4. Survival status for all patients [ Time Frame: 6 months ]
  5. 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

  6. 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)

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

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

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

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

  13. 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

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

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372176


Locations
Denmark
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)
Investigators
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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Matilde Jo Allingstrup, PhD Fellow, MSc Clinical Nutrition, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01372176     History of Changes
Other Study ID Numbers: 2011-002547-94
First Posted: June 13, 2011    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017

Keywords provided by Matilde Jo Allingstrup, Rigshospitalet, Denmark:
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

Additional relevant MeSH terms:
Critical Illness
Muscular Atrophy
Disease Attributes
Pathologic Processes
Neuromuscular Manifestations
 Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms