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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Mechanical Ventilation; Muscle Wasting; Intensive Care (ICU) Myopathy; Loss of Physical Function
• Intervention / Treatment: Other: Early Goal-Directed Nutrition; Other: ASPEN-guidelines

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Department of Intensive Care, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Goal-Directed Nutrition	Other: Early Goal-Directed Nutrition; 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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical function	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	6 months after randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		28 days
Mortality		90 days
Mortality		6 months
Survival status for all patients		6 months
New organ failure in the ICU	SOFA score above 3 in every category ex. Glasgow Coma Scale Score	Followed until ICU discharge, an expected average of 21 days
Metabolic control	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)	Followed until ICU discharge, an expected average of 21 days
New onset of renal replacement therapy		Followed until ICU discharge, an expected average of 21 days
Accumulated energy- and protein balance		Followed until ICU discharge, an expected average of 21 days
Length of stay in ICU	Among survivors	Up to 52 weeks
Length of stay in hospital	Among survivors	Up to 52 weeks
Serious adverse reactions in ICU	Severe allergic reactions or elevated levels of liver enzymes in plasma	Up to 52 weeks
Health related quality of life	Assessed by SF-36 questionnaire	6 months after randomisation
Rate of nosocomial infections	Defined in six subcategories by a person blinded for the intervention	Followed until ICU discharge, an expected average of 21 days
Percent days alive without inotropic/vasopressor support at day 90		Up to 90 days
Percent days alive without renal replacement therapy at day 90		Up to 90 days
Percent days alive without mechanical ventilation at day 90		Up to 90 days
Cost analyses		Up to 52 weeks

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: University of Copenhagen; European Society for Clinical Nutrition and Metabolism; Fresenius Kabi
• 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: June 6, 2011
• First Submitted That Met QC Criteria: June 10, 2011
• First Posted (Estimate): June 13, 2011

Study Record Updates

• Last Update Posted (Estimate): January 5, 2017
• Last Update Submitted That Met QC Criteria: January 4, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Intensive care unit; Critical illness; Mortality; Indirect calorimetry; Reduced quality of life; Loss of lean body mass; Loss of physical function; Optimised nutritional support; Early initiation of nutrition
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease Attributes; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Atrophy; Muscular Atrophy; Critical Illness
• Other Study ID Numbers: 2011-002547-94