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

NCT05647135 | Recruiting

• 1 other identifier: rospen9accumulate
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Metabolism; Trauma; Nutritional Deficiency; Protein Malnutrition; Gastroparesis; Muscle Loss; Calorie Malnutrition Protein

Keywords

enteral nutrition; multiple trauma; energy target; protein target; body composition; gastric residual volume; enteral nutrition intolerance

Outcome Measures

Primary Outcomes (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

  on day 5 days

• 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

  on day 10

Secondary Outcomes (18)

• Ultrasound-guided assessment of gastric residual volume

  on day 5

• Ultrasound-guided assessment of gastric residual volume

  on day 10

• Muscle function

  24 hours after extubation

• Muscle function

  5 days after extubation

• Body composition - Fat-free body mass

  24 hours after extubation

Study Arms (2)

Group A

Group A - enteral formula with 6.3 g/100 ml protein

Other: Medical food

Group B

enteral formula with 10 g/100 ml protein

Other: Medical food

Interventions

Medical food OTHER

enteral formulas with different protein composition

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients with multiple trauma intubated and mechanical ventilated, admitted to the intensive care unit (ICU)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Romanian Society for Enteral and Parenteral Nutrition: lead

Study Sites (1)

Clinical Emergency Hospital of Bucharest

Bucharest, Romania

RECRUITING

Related Publications (5)

• van Zanten ARH, Petit L, De Waele J, Kieft H, de Wilde J, van Horssen P, Klebach M, Hofman Z. Very high intact-protein formula successfully provides protein intake according to nutritional recommendations in overweight critically ill patients: a double-blind randomized trial. Crit Care. 2018 Jun 12;22(1):156. doi: 10.1186/s13054-018-2070-5.

  PMID: 29895309 RESULT

• Singer P. Protein metabolism and requirements in the ICU. Clin Nutr ESPEN. 2020 Aug;38:3-8. doi: 10.1016/j.clnesp.2020.03.026. Epub 2020 May 31.

  PMID: 32690175 RESULT

• Tedeschi-Jockers F, Reinhold S, Hollinger A, Tuchscherer D, Kiss C, Gantner L, Ledergerber K, Zimmermann S, Scheuzger J, Huber J, Siegemund M. 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. Eur J Clin Nutr. 2022 Mar;76(3):419-427. doi: 10.1038/s41430-021-00956-9. Epub 2021 Jun 24.

  PMID: 34168292 RESULT

• Berger MM, Reintam-Blaser A, Calder PC, Casaer M, Hiesmayr MJ, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Bischoff SC, Singer P. Monitoring nutrition in the ICU. Clin Nutr. 2019 Apr;38(2):584-593. doi: 10.1016/j.clnu.2018.07.009. Epub 2018 Jul 20.

  PMID: 30077342 RESULT

• Yasuda H, Kondo N, Yamamoto R, Asami S, Abe T, Tsujimoto H, Tsujimoto Y, Kataoka Y. Monitoring of gastric residual volume during enteral nutrition. Cochrane Database Syst Rev. 2021 Sep 27;9(9):CD013335. doi: 10.1002/14651858.CD013335.pub2.

  PMID: 34596901 RESULT

MeSH Terms

Conditions

Wounds and Injuries; Malnutrition; Kwashiorkor; Gastroparesis; Muscular Atrophy; Protein-Energy Malnutrition; Multiple Trauma

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Severe Acute Malnutrition; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Protein Deficiency; Deficiency Diseases

Study Officials

• Ioana Grintescu, MD, PhD

  Romanian Society of Enteral and Parenteral Nutrition

  STUDY DIRECTOR

Central Study Contacts

Ioana Grintescu, MD, PhD

CONTACT

+40722329187; ioana.grintescu@rospen.ro

Cristian Cobilinschi, MD, PhD

CONTACT

+40765018776; cristian.cobilinschi@umfcd.ro

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: December 12, 2022
• Study Start: March 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2024 3 years
• Access Criteria: Interest in data analysis, appropriate background in the field

Locations

RO (1)