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 mitochondrial function in addition to long-term physical function and 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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor)
Official Title:	Early Goal-Directed Nutrition in ICU Patients - EAT-ICU Trial

Resource links provided by NLM:

MedlinePlus related topics: Health Checkup Nutritional Support

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

Physical function [ Time Frame: 6 months after randomisation ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Mortality [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
New organ failure in the ICU [ Time Frame: Followed until ICU discharge, an expected average of 21 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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)
Rate and length of dialysis [ Time Frame: Followed until ICU discharge, an expected average of 21 days ] [ Designated as safety issue: No ]
Length of mechanical ventilation [ Time Frame: Followed until ICU discharge, an expected average of 21 days ] [ Designated as safety issue: No ]
Among survivors
Accumulated energy- and protein balance [ Time Frame: Followed until ICU discharge, an expected average of 21 days ] [ Designated as safety issue: No ]
Length of stay in ICU [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
Among survivors
Length of stay in hospital [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
Among survivors
Serious adverse reactions [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
Severe allergic reactions or elevated levels of liver enzymes in plasma
Hand grip strength [ Time Frame: Followed until ICU discharge, an expected average of 21 days ] [ Designated as safety issue: No ]
First and last measurement and AUC for the entire ICU admission for each patient
Health related quality of life [ Time Frame: 6 months after randomisation ] [ Designated as safety issue: No ]
Assessed by SF-36 questionnaire
Number of mitochondria and -function [ Time Frame: Followed until ICU discharge, an expected average of 21 days ] [ Designated as safety issue: No ]
Peripheral blood mononuclear mitochondrial DNA/nuclear DNA ratio
Rate of nosocomial infections [ Time Frame: Followed until ICU discharge, an expected average of 21 days ] [ Designated as safety issue: No ]
Defined in six subcategories by a person blinded for the intervention
Days on inotropic/vasopressor support [ Time Frame: Followed until ICU discharge, an expected average of 21 days ] [ Designated as safety issue: No ]
Among survivors
Cost analyses [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]


Estimated Enrollment:	200
Study Start Date:	June 2013
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	June 2015 (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
Genders Eligible for Study:	Both
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)

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
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

Contacts


Contact: Matilde Jo Allingstrup, PhD Student, M.Sc.	+ 45 3545 8415	matilde.allingstrup@rh.regionh.dk
Contact: Anders Perner, Professor, M.D., PhD.	+ 45 3545 4131	anders.perner@rh.regionh.dk

Locations


Denmark
Department of Intensive Care, Rigshospitalet	Recruiting
Copenhagen, Denmark, 2100
Contact: Matilde Jo Allingstrup, PhD Student, M.Sc. +45 3545 8415 matilde.allingstrup@rh.regionh.dk
Contact: Anders Perner, Professor, M.D., PhD. + 45 3545 4131 anders.perner@rh.regionh.dk
Principal Investigator: Anders Perner, Professor, M.D., PhD.

Sponsors and Collaborators

Rigshospitalet, Denmark

Copenhagen Trial Unit, Center for Clinical Intervention Research

University of Copenhagen

Fresenius Kabi

Investigators


Principal Investigator:	Anders Perner, Professor, M.D., PhD.	Rigshospitalet, Department of Intensive Care
Study Director:	Matilde Jo Allingstrup, PhD Student, M.Sc.	Rigshospitalet, Department of Intensive Care

More Information

No publications provided


Responsible Party:	Matilde Jo Allingstrup, PhD Student, M.Sc. 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:	June 27, 2013
Health Authority:	Denmark: Danish Dataprotection Agency Denmark: Danish Medicines Agency Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by 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 Disease Attributes Pathologic Processes

ClinicalTrials.gov processed this record on March 03, 2015