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Clinical Trials/EUCTR2011-002547-94-DK
EUCTR2011-002547-94-DK
Active, not recruiting
Phase 1

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

Dept. of Intensive Care 4131, Rigshospitalet0 sites200 target enrollmentMarch 25, 2013
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ConditionsAcutely admitted, mechanically ventilated intensive care unit patients.MedDRA version: 15.1Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 15.1Level: LLTClassification code 10028151Term: Multi organ failureSystem Organ Class: 100000004867Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
DrugsGlucos. 500mg/ml Fresenius KabiVamin 18 g N/l elektrolytfriSMOFlipidMixamin Glucos 120 mg/mlSmofKabivenVitalipid AdultSoluvitTracel

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Acutely admitted, mechanically ventilated intensive care unit patients.
Sponsor
Dept. of Intensive Care 4131, Rigshospitalet
Enrollment
200
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 25, 2013
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Dept. of Intensive Care 4131, Rigshospitalet

Eligibility Criteria

Inclusion Criteria

  • •Patients will be randomised as soon as possible, and included and dosed at the latest 24 hours after admission to the ICU. Patients must meet all of the following criteria to be eligible for inclusion:
  • •1\.Age \= 18 years
  • •2\.Acutely admitted to the ICU
  • •3\.Expected length of stay in ICU \> 3 days
  • •4\.Mechanically ventilated, which enables indirect calorimetry
  • •5\.Have a central venous catheter wherein PN can be administered
  • •6\.Written informed consent obtained
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •Patients with one or more of the listed conditions will not be included, as they may have unique nutritional requirements:
  • •?Contraindications to use enteral nutrition
  • •?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 ? 17 or severe malnutrition
  • •?The clinician finds that the patient is too deranged (circulation, respiration, electrolytes etc.) or that death is imminent

Outcomes

Primary Outcomes

Not specified

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