NCT02837861: EMS

Early and Adequate Protein Feeding Post-Traumatic Injury

Completed EARLY_PHASE1 Last updated 27 October 2020

What this trial tests

EARLY_PHASE1 trial testing Routine Nutritional Support plus supplemental IV amino acids in Protein Feeding in Post-traumatic Injury Patients in 45 participants. Completed in 18 October 2019.

Timeline

7 March 2017

Primary endpoint
18 October 2019

18 October 2019

Quick facts

Lead sponsor	Boston Medical Center
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	45
Start date	7 March 2017
Primary completion	18 October 2019
Estimated completion	18 October 2019
Sites	1 location across United States

Drugs / interventions tested

• Routine Nutritional Support plus supplemental IV amino acids — full drug profile →
• Routine Nutritional Support

Conditions studied

• Protein Feeding in Post-traumatic Injury Patients — all drugs for Protein Feeding in Post-traumatic Injury Patients →

Sponsor

Boston Medical Center

Who can join

Adults 18 to 65, any sex, with Protein Feeding in Post-traumatic Injury Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A randomized, parallel-group, pilot study comparing the effect of the early addition of intravenous protein to enteral feeding as tolerated versus enteral feedings as tolerated alone immediately post traumatic injury.

Primary: To determine that early and adequate nutritional support will improve protein economy in the first week post -injury as measured by nitrogen balance. We hypothesize that an improvement in nitrogen balance with early maximized protein intake will support the production of acute phase proteins, major antioxidants and the inflammatory response.

Secondary: Through the use of mass spectrometry (MS) and nuclear magnetic resonance (NMR) technologies we will determine that our plan for early and adequate nutritional support with adequate protein from day one post injury will alter the metabolomics profile when compared to routine nutritional support.

Tertiary: For Specific Aim 3 we will measure several pro- and anti-inflammatory cytokines and soluble proteins.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Early enteral nutrition (within 48 hours) versus delayed enteral nutrition (after 48 hours) with or without supplemental parenteral nutrition in critically ill adults.
   Fuentes Padilla P, Martínez G, Vernooij RW, Urrútia G, et al · · 2019 · cited 62× · PMID 31684690 · DOI 10.1002/14651858.cd012340.pub2