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

Critical Illness Clinical Trial

— EAT-ICU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372176
• Other study ID #: 2011-002547-94
• Status: Completed
• Phase: Phase 4
• First received: June 6, 2011
• Last updated: January 4, 2017
• Start date: June 2013
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Critical Illness
• Intensive Care (ICU) Myopathy
• Loss of Physical Function
• Mechanical Ventilation
• Muscle Wasting
• Muscular Atrophy

Intervention

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).
• 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.

Locations

Country	Name	City	State
Denmark	Department of Intensive Care, Rigshospitalet	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Fresenius Kabi, The European Society for Clinical Nutrition and Metabolism (ESPEN), University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical function	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	6 months after randomisation	No
Secondary	Mortality		28 days	No
Secondary	Mortality		90 days	No
Secondary	Mortality		6 months	No
Secondary	Survival status for all patients		6 months	No
Secondary	New organ failure in the ICU	SOFA score above 3 in every category ex. Glasgow Coma Scale Score	Followed until ICU discharge, an expected average of 21 days	No
Secondary	Metabolic control	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)	Followed until ICU discharge, an expected average of 21 days	No
Secondary	New onset of renal replacement therapy		Followed until ICU discharge, an expected average of 21 days	No
Secondary	Accumulated energy- and protein balance		Followed until ICU discharge, an expected average of 21 days	No
Secondary	Length of stay in ICU	Among survivors	Up to 52 weeks	No
Secondary	Length of stay in hospital	Among survivors	Up to 52 weeks	No
Secondary	Serious adverse reactions in ICU	Severe allergic reactions or elevated levels of liver enzymes in plasma	Up to 52 weeks	Yes
Secondary	Health related quality of life	Assessed by SF-36 questionnaire	6 months after randomisation	No
Secondary	Rate of nosocomial infections	Defined in six subcategories by a person blinded for the intervention	Followed until ICU discharge, an expected average of 21 days	No
Secondary	Percent days alive without inotropic/vasopressor support at day 90		Up to 90 days	No
Secondary	Percent days alive without renal replacement therapy at day 90		Up to 90 days	No
Secondary	Percent days alive without mechanical ventilation at day 90		Up to 90 days	No
Secondary	Cost analyses		Up to 52 weeks	No