Boston Medical Center
Boston, Massachusetts, 02118, United States
NCT Number: NCT02837861
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.
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Notify Me18 year–65 year
All sexes
Interventional
Early Phase 1
Boston, Massachusetts, 02118, United States
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:
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Plenamine
Enteral nutrition as tolerated.
Time frame: 8 days
We will use the urine specimen collections to measure nitrogen balance and catabolic index, both of which assess the level of physiologic stress. A catabolic Index less than zero represents no significant stress, an index greater than or equal to zero and less than or equal to 5 represents moderate stress, and an index greater than 5 represents severe stress. Twenty-four hour urine collections will be done for measurement of urine urea nitrogen to estimate nitrogen balance on day 1 and day 5 or 6 or 7 of the study. This will allow us to compare degree of catabolism and nitrogen efficiency between groups as well as between the two time points (Day 1 and Day 5 or 6 or 7). We hypothesize the early and adequate protein feeding group, although receiving fewer overall calories than subjects' total requirements, will have less negative nitrogen balance than the control group.
Time frame: 8 days
Through the use of mass spectrometry (MS) and nuclear magnetic resonance (NMR) technologies we will determine whether 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. We expect:
Time frame: 8 days
Early and adequate protein support will modify the levels of select pro and anti-inflammatory cytokines levels as compared to standard nutritional care. We anticipate decreased levels of the stress response mediators such as cortisol, Tumor Necrosis Factor (TNF), Interleukin-6 (IL-8)and Interleukin-8 (IL-8). These inflammatory markers are also key regulators of the breakdown of muscle during the acute stress response and their down-regulation would also serve to protect lean muscle mass.
Boston Medical Center
Other
Early Metabolomic Support Study
Acronym: EMS
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