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

Rigshospitalet

Status and phase: Completed; Phase 4

Conditions: Loss of Physical Function; Critical Illness; Mechanical Ventilation; Muscle Wasting; Intensive Care (ICU) Myopathy

Treatments: Other: ASPEN-guidelines; Other: Early Goal-Directed Nutrition

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01372176

2011-002547-94

Details and patient eligibility

About

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.

Enrollment: 203 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

203 participants in 2 patient groups

Early Goal-Directed Nutrition

Experimental group

Treatment:

Other: Early Goal-Directed Nutrition

ASPEN-guidelines

Active Comparator group

Treatment:

Other: ASPEN-guidelines