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Early and Adequate Protein Feeding Post-Traumatic Injury (EMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02837861
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : October 27, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Boston Medical Center

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.


Condition or disease Intervention/treatment Phase
Protein Feeding in Post-traumatic Injury Patients Drug: Routine Nutritional Support plus supplemental IV amino acids Other: Routine Nutritional Support Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Early Metabolomic Support Study
Actual Study Start Date : March 7, 2017
Actual Primary Completion Date : October 18, 2019
Actual Study Completion Date : October 18, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Group
Routine Nutritional Support plus supplemental IV amino acids, to begin within 24h of injury. (Target approximately 1.5-2g protein/kg/day)
Drug: 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.
Other Name: Plenamine

Active Comparator: Control Group
Routine Nutritional Support (i.e. enteral nutrition as tolerated, to begin as early as medically feasible)
Other: Routine Nutritional Support
Enteral nutrition as tolerated.




Primary Outcome Measures :
  1. Nitrogen balance and Catabolic Index [ 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.


Secondary Outcome Measures :
  1. Metabolomics Profiles [ 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:

    1. An improvement in protein (specifically branched chain amino acid) utilization with reduced 3-methylhistidine production and decreased proteolysis from peripheral stores;
    2. Improved redox potential as measured by products of oxidation: primarily glutathione precursors and metabolites and products of lipid peroxidation;
    3. 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).


Other Outcome Measures:
  1. Inflammatory Biomarkers [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837861


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Peter A Burke, MD Boston Medical Center
Publications:
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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT02837861    
Other Study ID Numbers: H-34322
1R21DK108145-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: A Data and Safety Monitoring Safety plan has been created per Boston University Medical Campus (BUMC) guidelines. The Principal Investigator at Boston Medical Center (BMC) or Boston University Medical Campus will report all adverse events and Unanticipated Problems to the Institutional Review Board (IRB) in compliance with IRB policy, Federal/State regulations, and sponsor requirements.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Medical Center:
Metabolic Support
Nutritional Support
Neuro-endocrine Event
Enteral feedings
Parenteral feeding
Additional relevant MeSH terms:
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Wounds and Injuries