RecruitingNot Applicable

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

Romania70 participantsStarted 2023-03-01

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Patients with recent gastrointestinal surgical intervention * Patients on chronic therapy with corticosteroids

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Calorie and protein target

Timeframe: on day 5 days

Calorie and protein target

Timeframe: on day 10

Trial details

NCT IDNCT05647135

SponsorRomanian Society for Enteral and Parenteral Nutrition

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-01

Contact for this trial

Ioana Grintescu, MD, PhD

+40722329187 ioana.grintescu@rospen.ro

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