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CompletedNCT01372176

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
203 (actual)
Sponsor
Rigshospitalet, Denmark · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHEREarly Goal-Directed Nutrition1. 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).
OTHERASPEN-guidelinesEN 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.

Timeline

Start date
2013-06-01
Primary completion
2016-11-01
Completion
2016-11-01
First posted
2011-06-13
Last updated
2017-01-05

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT01372176. Inclusion in this directory is not an endorsement.