About this trial
This prospective observational randomized study aims to determine energy, protein intake and gastrointestinal tolerance while using enteral nutrition formulas with very high protein content and enteral nutrition formulas with normal protein content.
* Differences regarding achieving protein and calorie daily targets when using enteral nutrition formulas with different protein content * Differences regarding residual gastric volume when using enteral nutrition formulas with different protein content * Differences regarding body composition when using enteral nutrition formulas with different protein content
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (>18 yrs) admitted to the ICU
Multiple trauma (Injury severity score > 18)
Intubation and mechanical ventilation upon admission in ICU or during the first 24 hours of admission, for at least 48 h
Disqualifiers
Age < 18 years
Pregnant women
Patients not intubated or not mechanically ventilated or receiving only non-invasive ventilation
Patients with enteral feeding contraindication 48 h after admission
Trial population
Consecutive patients with multiple trauma intubated and mechanical ventilated, admitted to the intensive care unit (ICU)
Trial design
Cohort
Prospective
Treatments tested in this trial
Medical food
Other interventionenteral formulas with different protein composition
Treatment groups
Trial outcomes
Primary outcomes
Calorie and protein target
Differences regarding achieving protein and calorie daily targets in grams per kilogram of body weight (g/kg BW) at day 5 of the intervention period and at day 10 when using enteral nutrition formulas with different protein content
Calorie and protein target
Differences regarding achieving protein and calorie daily targets in grams per kilogram of body weight (g/kg BW) at day 5 of the intervention period and at day 10 when using enteral nutrition formulas with different protein content
Secondary outcomes
Ultrasound-guided assessment of gastric residual volume
Differences regarding residual gastric volume when using enteral nutrition formulas with different protein content. Ultrasound assessment of gastric volume using a current model for GV assessment based on antral cross-sectional area (CSA) - GV (ml)1⁄427.0+14.6×right-lateral CSA (cm2)21.28×age (yr)
Ultrasound-guided assessment of gastric residual volume
Differences regarding residual gastric volume when using enteral nutrition formulas with different protein content. Ultrasound assessment of gastric volume using a current model for GV assessment based on antral cross-sectional area (CSA) - GV (ml)1⁄427.0+14.6×right-lateral CSA (cm2)21.28×age (yr)
Muscle function
Muscle function evaluation using handgrip dynamometer after extubation and sedation cessation
Muscle function
Muscle function evaluation using handgrip dynamometer after extubation and sedation cessation
Sponsors and contacts
Click on the lead sponsor to view all of their trials.