drugset / Trial / NCT02837861

Early and Adequate Protein Feeding Post-Traumatic Injury

NCT02837861

RandomizedParallel-groupOpen-labelSupportive care

Summary

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.

Timeline

Start
2017-03-07
Primary completion
2019-10-18
Completion
2019-10-18

Drugs

EvaluationDrugModalityDoseRoute
Subject amino acids Unknown 1.5 g/kg Intravenous
Subject amino acids Unknown 2 g/kg Intravenous

Indications

No indication recorded.