Early Goal-Directed Nutrition in ICU Patients - EAT-ICU Trial (EAT-ICU)
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ClinicalTrials.gov Identifier: NCT01372176 |
Recruitment Status
:
Completed
First Posted
: June 13, 2011
Last Update Posted
: January 5, 2017
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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 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 |
Arm | Intervention/treatment |
---|---|
Experimental: Early Goal-Directed Nutrition |
Other: Early Goal-Directed Nutrition
|
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.
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- 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
- Mortality [ Time Frame: 28 days ]
- Mortality [ Time Frame: 90 days ]
- Mortality [ Time Frame: 6 months ]
- Survival status for all patients [ Time Frame: 6 months ]
- 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
- 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)
- New onset of renal replacement therapy [ Time Frame: Followed until ICU discharge, an expected average of 21 days ]
- Accumulated energy- and protein balance [ Time Frame: Followed until ICU discharge, an expected average of 21 days ]
- Length of stay in ICU [ Time Frame: Up to 52 weeks ]Among survivors
- Length of stay in hospital [ Time Frame: Up to 52 weeks ]Among survivors
- Serious adverse reactions in ICU [ Time Frame: Up to 52 weeks ]Severe allergic reactions or elevated levels of liver enzymes in plasma
- Health related quality of life [ Time Frame: 6 months after randomisation ]Assessed by SF-36 questionnaire
- 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
- Percent days alive without inotropic/vasopressor support at day 90 [ Time Frame: Up to 90 days ]
- Percent days alive without renal replacement therapy at day 90 [ Time Frame: Up to 90 days ]
- Percent days alive without mechanical ventilation at day 90 [ Time Frame: Up to 90 days ]
- Cost analyses [ Time Frame: Up to 52 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372176
Denmark | |
Department of Intensive Care, Rigshospitalet | |
Copenhagen, Denmark, 2100 |
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
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 |