Early and Adequate Protein Feeding Post-Traumatic Injury
NCT ID: NCT02837861
Last Updated: 2020-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
EARLY_PHASE1
45 participants
INTERVENTIONAL
2017-03-07
2019-10-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental Group
Routine Nutritional Support plus supplemental IV amino acids, to begin within 24h of injury. (Target approximately 1.5-2g protein/kg/day)
Routine Nutritional Support plus supplemental IV amino acids
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.
Control Group
Routine Nutritional Support (i.e. enteral nutrition as tolerated, to begin as early as medically feasible)
Routine Nutritional Support
Enteral nutrition as tolerated.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Routine Nutritional Support plus supplemental IV amino acids
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.
Routine Nutritional Support
Enteral nutrition as tolerated.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institutes of Health (NIH)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Boston Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peter A Burke, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Boston Medical Center
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-34322
Identifier Type: -
Identifier Source: org_study_id