Early and Adequate Protein Feeding Post-Traumatic Injury
Condition: Protein Feeding in Post-traumatic Injury Patients
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Early Phase 1

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.
    

Detailed description: 
      -  Subjects admitted to the trauma service and cared for in the SICU will be screened for
           participation in this study.

        -  If subjects meet eligibility criteria, they will be enrolled and randomized 1:1 to
           enteral nutrition alone or enteral nutrition plus Amino Acid (AA) infusions.

        -  Nutritional assessment will be completed.

        -  Various procedures/assessments will take place over the course of the trial.

        -  Subjects will be followed for 28 days or until discharged or disposition of status.

      Potential subjects deemed eligible will be randomized by the REDCap Randomization Module and
      begin study interventions within the first 24 hours of admission to the Surgical Intensive
      Care Unit (SICU).

      Subjects enrolled into the Control Arm will receive routine nutritional support (RNS). RNS
      for the purpose of this study is defined as:

        -  Nutrition delivered via the enteral route of administration;

        -  Enteral caloric goal of 60-80% of energy requirements;

        -  Enteral feedings to be initiated as soon as medically feasible;

        -  Full parenteral nutrition to be initiated on Day 7 if enteral nutrition has not been
           started. Subjects will complete the study after Day 5 and will continue with nutritional
           support as clinically indicated.

      Subjects enrolled into the Experimental Arm will receive RNS plus supplemental intravenous
      amino acids (RNS+IVAA). RNS+IVAA for the purpose of this study is defined as:

        -  Nutrition delivered via the enteral route of administration;

        -  Enteral caloric goal of 60-80% of energy requirements;

        -  Enteral feedings to be initiated as soon as medically feasible;

        -  Full parenteral nutrition to be initiated on Day 7 if enteral nutrition has not been
           started.

        -  Supplemental intravenous amino acids to begin within 24 hours of admission to the
           Surgical Intensive Care Unit (SICU);

        -  Amino acids to supplement enteral protein for total protein intake of approximately
           1.5-2g/kg/day. Subjects will complete the study after Day 5 and will continue with
           nutritional support as clinically indicated.

      Allocation of Treatment and Randomization Procedures 40 subjects will be recruited into the
      study and will be randomized in a 1:1 ratio. This will take place in lots of 10; permitting
      evaluation of data after every ten subjects. Potential subjects deemed eligible will be
      randomized in a blinded fashion by the REDCap Randomization Module to receive either routine
      nutritional support , enteral feedings as soon as medically feasible supplemented with
      intravenous amino acids " or routine nutritional support enteral feedings as soon as
      medically feasible. Randomization treatment assignment list will be created by our
      statistician; taking into consideration drop outs and replacements.
    

Intervention name(s): Routine Nutritional Support plus supplemental IV amino acids; Routine Nutritional Support
Intervention type(s): Drug; Other
Intervention description(s): Enteral nutrition as tolerated Plus supplemental IV AA infusion to meet the target of approximately 1.5-2.0gm protein/kg/day total starting within 24 hours of injury for 5 days.; Enteral nutrition as tolerated.
Other intervention name(s): Plenamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Metabolic Support; Nutritional Support; Neuro-endocrine Event; Enteral feedings; Parenteral feeding