Clinical trial NCT02837861: Early and Adequate Protein Feeding Post-Traumatic Injury
Official title: Early Metabolomic Support Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Protein Feeding in Post-traumatic Injury Patients
Keywords: Metabolic Support
Nutritional Support
Neuro-endocrine Event
Enteral feedings
Parenteral feeding
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-07-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility 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

Primary outcomes:
measure: Nitrogen balance and Catabolic Index
timeFrame: 8 days
Secondary outcomes:
measure: Metabolomics Profiles
timeFrame: 8 days
Other outcomes:
measure: Inflammatory Biomarkers
timeFrame: 8 days
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Peter A Burke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Casaer MP, Mesotten D, Hermans G, Wouters PJ, Schetz M, Meyfroidt G, Van Cromphaut S, Ingels C, Meersseman P, Muller J, Vlasselaers D, Debaveye Y, Desmet L, Dubois J, Van Assche A, Vanderheyden S, Wilmer A, Van den Berghe G. Early versus late parenteral nutrition in critically ill adults. N Engl J Med. 2011 Aug 11;365(6):506-17. doi: 10.1056/NEJMoa1102662. Epub 2011 Jun 29.
citation: Hill AA, Plank LD, Finn PJ, Whalley GA, Sharpe N, Clark MA, Hill GL. Massive nitrogen loss in critical surgical illness: effect on cardiac mass and function. Ann Surg. 1997 Aug;226(2):191-7. doi: 10.1097/00000658-199708000-00011.
citation: Sandstrom R, Drott C, Hyltander A, Arfvidsson B, Schersten T, Wickstrom I, Lundholm K. The effect of postoperative intravenous feeding (TPN) on outcome following major surgery evaluated in a randomized study. Ann Surg. 1993 Feb;217(2):185-95. doi: 10.1097/00000658-199302000-00013.