Early and Adequate Protein Feeding Post-Traumatic Injury
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/26/2018 |
| Start Date: | March 7, 2017 |
| End Date: | January 31, 2021 |
| Contact: | Peter A Burke, MD |
| Email: | Peter.Burke@bmc.org |
| Phone: | 617-414-5204 |
Early Metabolomic Support Study
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.
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.
- 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.
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.
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
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