Personalized Nutrition to Improve Recovery in Trauma

Study Overview
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Brief Summary
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The purpose of this study is to determine if a particular method of providing nutrition improves the outcomes of patients in the intensive care unit (ICU) who have undergone abdominal surgery following trauma and would require nutrition delivered via the bloodstream (called total parenteral nutrition or TPN). The nutrition method being tested is a structured nutrition delivery plan, called the SeND Home pathway, that involves TPN, oral nutrition supplements, and the use of a device (called an indirect calorimeter or IC) to measure calorie needs. Participants will be randomly assigned (like the flip of a coin) to the SeND Home program or standard of care nutrition. In the SeND Home program, participants will receive TPN, followed by oral nutrition supplements (shakes) for 4 weeks after discharge. The control group will follow standard of care nutrition delivery that begins during ICU stay and concludes at hospital discharge. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass and complete walking and strength tests, and surveys about quality of life.

Detailed Description
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Severe abdominal trauma can impact patients in a variety of ways. Current data shows that trauma patients can experience problems with physical function, muscle weakness, and poor quality of life after they are released from the hospital. There is a critical need to improve nutrition in trauma patients with severe abdominal injuries to optimize the recovery process. The purpose of this study is to evaluate if the use of a planned nutrition delivery plan with early intravenous (IV) nutrition will improve outcomes. Participants will be randomly assigned 1:1, like flipping a coin, to the SeND Home program or routine care. Participants in the standard of care program will receive standard nutrition delivery as determined by clinical care providers. This may include TPN. Participants in the SeND Home program will receive TPN within 72 hours of abdominal surgery. Indirect calorimetry will be used to determine nutrition needs.Once participants are able to have a liquid diet they will receive nutrition shakes up to 3 times a day while in the hospital and for 4 weeks after discharge. Participants will undergo tests to measure muscle mass, have blood draws, complete walking and strength tests, and surveys about quality of life. These tests will be done at several times throughout hospitalization and participants will be asked to return for a 3 month follow-up visit.

Official Title
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Personalized Targeted Nutrition Via StructurEd Nutrition Delivery Pathway to Improve Recovery of Physical Function in Trauma

Conditions
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Abdominal Trauma

Intervention / Treatment
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* Dietary Supplement: Nutrition Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18+ years old Penetrating abdominal trauma requiring emergent major abdominal surgery Admitted to the surgical ICU Not expected to receive oral nutrition for 72 hours or more Exclusion Criteria: Patients who are unable to ambulate at baseline Expected withdrawal of life-sustaining treatment within 48 hours Prisoners Positive pregnancy test for women of child bearing potential.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SeND Home Pathway<br>Total parenteral nutrition (TPN) will begin within 72 hours of abdominal surgery. Calorie needs will be determined by indirect calorimetry. Nutritional shakes will begin when a liquid diet is started. These will be taken 3 times a day while in the hospital and for 4 weeks after discharge. | Dietary Supplement: Nutrition Supplement<br>* Total parenteral nutrition (TPN) will be administered within 72 hours of abdominal surgery. Nutritional shakes will be started with a liquid diet and given 3 times a day. This will continue for 4 weeks after discharge.<br>* Other names: Nutritional shakes;|
| No Intervention: Standard Nutrition<br>Standard nutrition as determined by clinical providers. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in six-minute walk distance (6 MWD) | Change in 6MWD from baseline to day 14 or hospital discharge will be compared between the two study arms | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical function | This will be measured by comparing the changes in physical function tests (4 meter walk, sit-to-stand) between the two study arms. | baseline, day 14 or hospital discharge, 3 and 6 months post-hospital discharge | 
| Change in muscle strength | This will be measured by comparing the changes in grip and quad strength tests between the two study arms. | baseline, hospital discharge, 3 and 6 months post-hospital discharge | 
| Change in muscle mass | This will be measured by comparing changes in bioelectrical impedance analysis (BIA) between the two study arms. | baseline, hospital discharge, 3 and 6 months post-hospital discharge | 
| Change in Quality of Life (QoL) | This will be measured by comparing changes in the EuroQoL-5 Dimension and 43-item Trauma Specific Quality of Life measurement between the two study arms. | baseline, 3 and 6 months post-hospital discharge | 
| Change in cognition | This will be measured by looking at changes in mental health and cognition via questionnaires. | baseline, 3 and 6 months post-hospital discharge | 
| Infection | This will be measured by looking at the number of infections reported. | hospital discharge, 3 and 6 months post-hospital discharge | 
| Length of Hospital/ICU stay | This will be measured by recording the length of hospital stay noted in the medical record. | hospital discharge | 
| Mortality rate | This will be measured by survival after 6 months. | 6 months post-hospital discharge | 
| Change in muscle mitochondrial metabolism | This will be measured by doing urine and blood tests. | admission, day 14, and hospital discharge | 
| Change in key resilience and inflammation biomarkers | This will be measured utilizing the Duke Pepper Panel which serves as a comprehensive set of biological indicators typically incorporating: hormones, inflammatory markers and genomic factors. | admission, day 14, and hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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precision nutrition, critical care, trauma, parenteral nutrition, indirect calorimetry