ImpACt of Very High Protein Content Enteral nUtrition Formulas on Critically Ill MUltipLe trAuma paTiEnts

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRomanian Society for Enteral and Parenteral Nutrition

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Medical food

    Other intervention

    enteral formulas with different protein composition

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Group A1 intervention
Group B: Group B1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
on day 5 days
2

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

Time frame
on day 10

Secondary outcomes

1

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)

Time frame
on day 5
2

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)

Time frame
on day 10
3

Muscle function

Muscle function evaluation using handgrip dynamometer after extubation and sedation cessation

Time frame
24 hours after extubation
4

Muscle function

Muscle function evaluation using handgrip dynamometer after extubation and sedation cessation

Time frame
5 days after extubation

Other outcomes

Sponsors and contacts

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