NCT05647135 ImpACt of Very High Protein Content Enteral nUtrition Formulas on Critically Ill MUltipLe trAuma paTiEnts
| NCT ID | NCT05647135 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Romanian Society for Enteral and Parenteral Nutrition |
| Condition | Metabolism |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2024-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2023-03-01 with a primary completion date of 2024-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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
Contact & Investigator
Ioana Grintescu, MD, PhD
STUDY DIRECTOR
Romanian Society of Enteral and Parenteral Nutrition
Frequently Asked Questions
Who can join the NCT05647135 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metabolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05647135 currently recruiting?
Yes, NCT05647135 is actively recruiting participants. Contact the research team at ioana.grintescu@rospen.ro for enrollment information.
Where is the NCT05647135 trial being conducted?
This trial is being conducted at Bucharest, Romania.
Who is sponsoring the NCT05647135 clinical trial?
NCT05647135 is sponsored by Romanian Society for Enteral and Parenteral Nutrition. The principal investigator is Ioana Grintescu, MD, PhD at Romanian Society of Enteral and Parenteral Nutrition. The trial plans to enroll 70 participants.