Clinical trial NCT01372176: Early Goal-Directed Nutrition in ICU Patients - EAT-ICU Trial
Official title: Early Goal-Directed Nutrition in ICU Patients - EAT-ICU Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Critical Illness
Intensive Care (ICU) Myopathy
Muscle Wasting
Loss of Physical Function
Mechanical Ventilation
Keywords: 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
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Fresenius Kabi
name: European Society for Clinical Nutrition and Metabolism
First posted: 2011-06-13
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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

Primary outcomes:
measure: Physical function
timeFrame: 6 months after randomisation
Secondary outcomes:
measure: Mortality
timeFrame: 28 days
measure: Mortality
timeFrame: 90 days
measure: Mortality
timeFrame: 6 months
measure: Survival status for all patients
timeFrame: 6 months
measure: New organ failure in the ICU
timeFrame: Followed until ICU discharge, an expected average of 21 days
measure: Metabolic control
timeFrame: Followed until ICU discharge, an expected average of 21 days
measure: New onset of renal replacement therapy
timeFrame: Followed until ICU discharge, an expected average of 21 days
measure: Accumulated energy- and protein balance
timeFrame: Followed until ICU discharge, an expected average of 21 days
measure: Length of stay in ICU
timeFrame: Up to 52 weeks
measure: Length of stay in hospital
timeFrame: Up to 52 weeks
measure: Serious adverse reactions in ICU
timeFrame: Up to 52 weeks
measure: Health related quality of life
timeFrame: 6 months after randomisation
measure: Rate of nosocomial infections
timeFrame: Followed until ICU discharge, an expected average of 21 days
measure: Percent days alive without inotropic/vasopressor support at day 90
timeFrame: Up to 90 days
measure: Percent days alive without renal replacement therapy at day 90
timeFrame: Up to 90 days
measure: Percent days alive without mechanical ventilation at day 90
timeFrame: Up to 90 days
measure: Cost analyses
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Intensive Care, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Department of Intensive Care
name: Anders Perner, Professor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Department of Intensive Care
name: Matilde Jo Allingstrup, PhD Fellow, MSc
role: STUDY_DIRECTOR
References:
citation: Allingstrup MJ, Kondrup J, Wiis J, Claudius C, Pedersen UG, Hein-Rasmussen R, Bjerregaard MR, Steensen M, Jensen TH, Lange T, Madsen MB, Moller MH, Perner A. Early goal-directed nutrition versus standard of care in adult intensive care patients: the single-centre, randomised, outcome assessor-blinded EAT-ICU trial. Intensive Care Med. 2017 Nov;43(11):1637-1647. doi: 10.1007/s00134-017-4880-3. Epub 2017 Sep 22.
citation: Allingstrup MJ, Kondrup J, Wiis J, Claudius C, Pedersen UG, Hein-Rasmussen R, Jensen TH, Lange T, Perner A. Early goal-directed nutrition in ICU patients (EAT-ICU): protocol for a randomised trial. Dan Med J. 2016 Sep;63(9):A5271.