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

Last updated: January 4, 2017
Sponsor: Rigshospitalet, Denmark
Overall Status: Completed

Phase

4

Condition

Muscular Dystrophy

Myasthenia Gravis (Chronic Weakness)

Polymyositis (Inflammatory Muscle Disease)

Treatment

N/A

Clinical Study ID

NCT01372176
2011-002547-94
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, whoare independent of the trial)

  • Must be able to understand Danish

Exclusion

Exclusion Criteria:

  • Contraindications to use enteral nutrition

  • Contraindications to use parenteral nutrition, eg. hypersensitivity towards fish-, eggor 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

Study Design

Total Participants: 203
Study Start date:
June 01, 2013
Estimated Completion Date:
November 30, 2016

Connect with a study center

  • Department of Intensive Care, Rigshospitalet

    Copenhagen, 2100
    Denmark

    Site Not Available

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