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Completed

NCT Number: NCT01372176

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

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.

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Key information

Conditions

Critical Illness Atrophy Disease Attributes Intensive Care (ICU) Myopathy Loss of Physical Function Mechanical Ventilation Muscle Wasting Muscular Atrophy Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Intensive Care, Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Goal-Directed Nutrition

Other
  • 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).

ASPEN-guidelines

Other

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • European Society for Clinical Nutrition and Metabolism
  • Fresenius Kabi
  • University of Copenhagen

Registry information

Acronym: EAT-ICU

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 13, 2011
Registry last updated
Jan 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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