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

NCT01372176 | Completed Phase 4 DMC

• 1 other identifier: 2011-002547-94
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (17)

• Mortality

  28 days

• Mortality

  90 days

• Mortality

  6 months

• Survival status for all patients

  6 months

• New organ failure in the ICU

  Followed until ICU discharge, an expected average of 21 days

Study Arms (2)

Early Goal-Directed Nutrition

EXPERIMENTAL

Other: Early Goal-Directed Nutrition

ASPEN-guidelines

ACTIVE COMPARATOR

Other: ASPEN-guidelines

Interventions

Early Goal-Directed Nutrition OTHER

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).

Early Goal-Directed Nutrition

ASPEN-guidelines OTHER

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.

ASPEN-guidelines

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• University of Copenhagen: collaborator
• Fresenius Kabi: collaborator
• European Society for Clinical Nutrition and Metabolism: collaborator

Study Sites (1)

Department of Intensive Care, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (2)

• Allingstrup MJ, Kondrup J, Wiis J, Claudius C, Pedersen UG, Hein-Rasmussen R, Bjerregaard MR, Steensen M, Jensen TH, Lange T, Madsen MB, Moller MH, Perner A. Early goal-directed nutrition versus standard of care in adult intensive care patients: the single-centre, randomised, outcome assessor-blinded EAT-ICU trial. Intensive Care Med. 2017 Nov;43(11):1637-1647. doi: 10.1007/s00134-017-4880-3. Epub 2017 Sep 22.

  PMID: 28936712 DERIVED

• Allingstrup MJ, Kondrup J, Wiis J, Claudius C, Pedersen UG, Hein-Rasmussen R, Jensen TH, Lange T, Perner A. Early goal-directed nutrition in ICU patients (EAT-ICU): protocol for a randomised trial. Dan Med J. 2016 Sep;63(9):A5271.

  PMID: 27585532 DERIVED

MeSH Terms

Conditions

Critical Illness; Muscular Diseases; Muscular Atrophy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Anders Perner, Professor, MD, PhD

  Rigshospitalet, Department of Intensive Care

  PRINCIPAL INVESTIGATOR

• Matilde Jo Allingstrup, PhD Fellow, MSc

  Rigshospitalet, Department of Intensive Care

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Fellow, MSc Clinical Nutrition

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 13, 2011
• Study Start: June 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 5, 2017

Record last verified: 2017-01

Locations

DK (1)