Early Goal-Directed Nutrition in ICU Patients - EAT-ICU Trial - Full Text View

Purpose

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	Intervention	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
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor)
Official Title:	Early Goal-Directed Nutrition in ICU Patients - EAT-ICU Trial

Further study details as provided by Matilde Jo Allingstrup, Rigshospitalet, Denmark:

Primary Outcome Measures:

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:

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 ]


Enrollment:	203
Study Start Date:	June 2013
Study Completion Date:	November 2016
Primary Completion Date:	November 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372176

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

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, 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
Study First Received:	June 6, 2011
Last Updated:	January 4, 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

ClinicalTrials.gov processed this record on June 27, 2017

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