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

Phase 4

Completed

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

• Registration Number: NCT01372176
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-06
• Study First Submitted QC: 2011-06-10
• Study First Posted: 2011-06-13
• Study Start: 2013-06
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-04
• Last Update Posted: 2017-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASPEN-guidelines	ASPEN-guidelines	-
Early Goal-Directed Nutrition	Early Goal-Directed Nutrition	-

Primary Outcome Measures

Name	Time	Method
Physical function	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

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

Trial Locations

Locations (1)

Department of Intensive Care, Rigshospitalet; 🇩🇰 Copenhagen, Denmark