Protein Feeding in Post-traumatic Injury Patients Clinical Trial
— EMSOfficial title:
Early Metabolomic Support Study
| Verified date | October 2020 |
| Source | Boston Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 45 |
| Est. completion date | October 18, 2019 |
| Est. primary completion date | October 18, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Boston Medical Center | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Boston Medical Center | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH) |
United States,
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. — View 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. — View Citation
Sandström R, Drott C, Hyltander A, Arfvidsson B, Scherstén T, Wickström 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Inflammatory Biomarkers | 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. | 8 days | |
| Primary | Nitrogen balance and Catabolic Index | 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. | 8 days | |
| Secondary | Metabolomics Profiles | 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:
An improvement in protein (specifically branched chain amino acid) utilization with reduced 3-methylhistidine production and decreased proteolysis from peripheral stores; Improved redox potential as measured by products of oxidation: primarily glutathione precursors and metabolites and products of lipid peroxidation; Improvement in the lipid milieu seen post injury to reflect expected inflammatory response and not reflect the metabolomics profile observed with developing MODS (i.e. increased glycerol heads of phospholipids as opposed to increased fatty acyl chain, creatinine and lactate). |
8 days |