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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Rigshospitalet, Denmark
Sponsor:
Collaborators:
Copenhagen Trial Unit, Center for Clinical Intervention Research
University of Copenhagen
Fresenius Kabi
Information provided by (Responsible Party):
Matilde Jo Allingstrup, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01372176
First received: June 6, 2011
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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 mitochondrial function in addition to long-term physical function and 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.


Condition Intervention Phase
Critical Illness
Intensive Care (ICU) Myopathy
Muscle Wasting
Loss of Physical Function
Mechanical Ventilation
Other: Early Goal-Directed Nutrition
Other: ASPEN-guidelines
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Early Goal-Directed Nutrition in ICU Patients - EAT-ICU Trial

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Physical function [ Time Frame: 6 months after randomisation ] [ Designated as safety issue: No ]
    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:
  • Mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • New organ failure in the ICU [ Time Frame: Followed until ICU discharge, an expected average of 21 days ] [ Designated as safety issue: No ]
    SOFA score above 3 in every category ex. Glasgow Coma Scale Score

  • Metabolic control [ Time Frame: Followed until ICU discharge, an expected average of 21 days ] [ Designated as safety issue: No ]
    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)

  • Rate and length of dialysis [ Time Frame: Followed until ICU discharge, an expected average of 21 days ] [ Designated as safety issue: No ]
  • Length of mechanical ventilation [ Time Frame: Followed until ICU discharge, an expected average of 21 days ] [ Designated as safety issue: No ]
    Among survivors

  • Accumulated energy- and protein balance [ Time Frame: Followed until ICU discharge, an expected average of 21 days ] [ Designated as safety issue: No ]
  • Length of stay in ICU [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
    Among survivors

  • Length of stay in hospital [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
    Among survivors

  • Serious adverse reactions [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
    Severe allergic reactions or elevated levels of liver enzymes in plasma

  • Hand grip strength [ Time Frame: Followed until ICU discharge, an expected average of 21 days ] [ Designated as safety issue: No ]
    First and last measurement and AUC for the entire ICU admission for each patient

  • Health related quality of life [ Time Frame: 6 months after randomisation ] [ Designated as safety issue: No ]
    Assessed by SF-36 questionnaire

  • Number of mitochondria and -function [ Time Frame: Followed until ICU discharge, an expected average of 21 days ] [ Designated as safety issue: No ]
    Peripheral blood mononuclear mitochondrial DNA/nuclear DNA ratio

  • Rate of nosocomial infections [ Time Frame: Followed until ICU discharge, an expected average of 21 days ] [ Designated as safety issue: No ]
    Defined in six subcategories by a person blinded for the intervention

  • Days on inotropic/vasopressor support [ Time Frame: Followed until ICU discharge, an expected average of 21 days ] [ Designated as safety issue: No ]
    Among survivors

  • Cost analyses [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early Goal-Directed Nutrition 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).
Active Comparator: ASPEN-guidelines 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372176

Contacts
Contact: Matilde Jo Allingstrup, PhD Student, M.Sc. + 45 3545 8415 matilde.allingstrup@rh.regionh.dk
Contact: Anders Perner, Professor, M.D., PhD. + 45 3545 4131 anders.perner@rh.regionh.dk

Locations
Denmark
Department of Intensive Care, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Matilde Jo Allingstrup, PhD Student, M.Sc.    +45 3545 8415    matilde.allingstrup@rh.regionh.dk   
Contact: Anders Perner, Professor, M.D., PhD.    + 45 3545 4131    anders.perner@rh.regionh.dk   
Principal Investigator: Anders Perner, Professor, M.D., PhD.         
Sponsors and Collaborators
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
University of Copenhagen
Fresenius Kabi
Investigators
Principal Investigator: Anders Perner, Professor, M.D., PhD. Rigshospitalet, Department of Intensive Care
Study Director: Matilde Jo Allingstrup, PhD Student, M.Sc. Rigshospitalet, Department of Intensive Care
  More Information

No publications provided

Responsible Party: Matilde Jo Allingstrup, PhD Student, M.Sc. Clinical Nutrition, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01372176     History of Changes
Other Study ID Numbers: 2011-002547-94
Study First Received: June 6, 2011
Last Updated: June 27, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:
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

Additional relevant MeSH terms:
Critical Illness
Muscular Atrophy
Disease Attributes
Pathologic Processes
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014