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

Conditions

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

Interventions

OTHER

Early Goal-Directed Nutrition

1. Initiation of early supplementary parenteral nutrition (≤ 24 hours of admission). 2. Measurement of requirements (indirect calorimetry, 24-hour urinary urea) leading to patient-specific, individualised and goal-directed nutritional therapy. 3. Intervention goal: delivering 100% of patient-specific requirements, measured or calculated throughout entire admission (EN+PN).

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.

Sponsors & Collaborators

• University of Copenhagen

  collaborator OTHER

• Fresenius Kabi

  collaborator INDUSTRY

• European Society for Clinical Nutrition and Metabolism

  collaborator OTHER

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Anders Perner, Professor, MD, PhD · Rigshospitalet, Department of Intensive Care

• Matilde Jo Allingstrup, PhD Fellow, MSc · Rigshospitalet, Department of Intensive Care

Study Design

Allocation

RANDOMIZED

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2016-11-30

Completion

2016-11-30

Countries

• Denmark

Study Locations