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

Phase 1

Conditions: Acutely 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 disorders
MedDRA version: 15.1Level: LLTClassification code 10028151Term: Multi organ failureSystem Organ Class: 100000004867
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2011-002547-94-DK

Lead Sponsor: Dept. of Intensive Care 4131, Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

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
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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
?Pregnancy
?The clinician finds that the patient is too deranged (circulation, respiration, electrolytes etc.) or that death is imminent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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. ;Secondary Objective: Not applicable.;Primary end point(s): Physical function 6 months after randomisation (physical component summary (PCS)-score of SF-36 (27;28)) conducted as phone-interview by a person blinded to the intervention.;Timepoint(s) of evaluation of this end point: 6 months after randomisation.

Secondary Outcome Measures