Actively Recruiting

Age: 18Years +
All Genders
ID05647135

Impact of Very High Protein Content Enteral Nutrition Formulas on Protein Metabolism and Gastric Volume in Critically Ill Multiple Trauma Patients

Led by Romanian Society for Enteral and Parenteral Nutrition · Updated on 2024-07-22

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to study how different protein amounts in enteral nutrition formulas affect energy and protein intake as well as gastrointestinal tolerance in critically ill patients with multiple trauma. The study addresses challenges faced by these patients, including high protein needs and nutritional risks due to repeated surgeries and diagnostic procedures. Researchers also want to learn how these formulas impact body composition and muscle function during recovery. Participants are randomly assigned to one of two groups receiving enteral nutrition formulas: one with a normal protein level (6.3 g/100 ml) and one with a very high protein level (10 g/100 ml). Nutrition starts early in the intensive care unit (ICU) with continuous feeding, and energy needs are monitored using indirect calorimetry. The study collects data on protein and calorie intake, gastric residual volume, and nutritional tolerance over time. During the study, patients receive regular ultrasound assessments of gastric residual volume and body composition, along with muscle function tests after extubation. Blood tests measure inflammation and nutritional markers on days 5 and 10. The main outcomes include achieving calorie and protein targets on days 5 and 10. Researchers also monitor safety through clinical signs like vomiting and diarrhea. The study plans to enroll over 70 patients and will follow them through ICU stay and recovery phases.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients over 18 years old admitted to the ICU
  • Multiple trauma with Injury Severity Score greater than 18
  • Intubated and mechanically ventilated upon ICU admission or within 24 hours for at least 48 hours
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Pregnant women
  • Patients not intubated or not mechanically ventilated or only receiving non-invasive ventilation
  • Patients with contraindication to enteral feeding 48 hours after admission
  • Patients with recent gastrointestinal surgery
  • Patients on chronic corticosteroid therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 10 days

Participants who are intubated and mechanically ventilated in the ICU are observed while receiving enteral nutrition formulas with different protein contents. Energy and protein intake along with gastrointestinal tolerance are monitored.

Daily ultrasound assessments of gastric residual volume and nutrition monitoring visits during ICU stay

Follow-up

Duration - Up to 5 days after extubation

Participants undergo assessments of muscle function and body composition after extubation to evaluate recovery and nutritional impact.

2 visits (24 hours and 5 days after extubation)

Trial Site Locations

Total: 1 location

1

Clinical Emergency Hospital of Bucharest

Bucharest, Romania

Actively Recruiting

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Research Team

I

Ioana Grintescu, MD, PhD

C

Cristian Cobilinschi, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Very high intact-protein formula successfully provides protein intake according to nutritional recommendations in overweight critically ill patients: a double-blind randomized trial.

Arthur R H van Zanten, Laurent Petit, Jan De Waele...

https://pubmed.ncbi.nlm.nih.gov/29895309

A new high protein-to-energy enteral formula with a whey protein hydrolysate to achieve protein targets in critically ill patients: a prospective observational tolerability study.

Franziska Tedeschi-Jockers, Simona Reinhold, Alexa Hollinger...

https://pubmed.ncbi.nlm.nih.gov/34168292