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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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; 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.

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, Senior)
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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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Allingstrup MJ, Kondrup J, Wiis J, Claudius C, Pedersen UG, Hein-Rasmussen R, Bjerregaard MR, Steensen M, Jensen TH, Lange T, Madsen MB, Møller 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). pii: A5271.

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
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