Early and Adequate Protein Feeding Post-Traumatic Injury

• Status: Completed
• Trial end date: 2019-10-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)

Criteria

Inclusion Criteria:

• Trauma Patient /Male or female, any race/ethnicity

• Expected to survive 72 hours

• Admitted to the SICU

• Expected to remain in the hospital for at least 7 days

• Candidates for enteral nutrition post-injury

Exclusion Criteria:

• BMI less than 18 mg/m2 or greater than 35 mg/m2

• Immunosuppressive disorders (i.e. Prednisone >20mg daily; Organ Transplant Recipient with active immunosuppression treatments, diagnosis of HIV/AIDS).

• Type I or Type II Diabetes

• Pregnancy

• Pre-existing renal dysfunction (creatinine >2.5mg/dL).

• Clear contraindication for enteral nutrition immediately post injury

• Severe liver dysfunction (Total Bilirubin > 3.0mg%)

• Non-English speaking patients

• Known allergies to any of the study drug's components