Personalized Nutrition to Improve Recovery in Trauma (SeND Home)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Trauma
• Intervention / Treatment: Dietary supplement: Nutrition Supplement

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Krista Haines, MD; Phone Number: 919-681-3784; Email: krista.haines@duke.edu
• Study Contact Backup: Name: Shauna Howell; Phone Number: 919-613-1588; Email: shauna.eggertson@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Hospital
      • Contact: Shauna Howell; Phone Number: 919-668-3771; Email: shauna.eggertson@duke.edu
      • Sub-Investigator: Krista Haines, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SeND Home Pathway; 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; 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.; Other Names: CLINIMIX E 8/14 sulfite-free; CLINOLIPID 20%; Nutritional shakes
No Intervention: Standard Nutrition; Standard nutrition as determined by clinical providers.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: United States Department of Defense; Baxter Healthcare Corporation
• Investigators: Principal Investigator: Paul Wischmeyer, MD, Duke

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: September 27, 2023
• First Posted (Actual): October 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: trauma; critical care; indirect calorimetry; parenteral nutrition; precision nutrition
• Additional Relevant MeSH Terms: Wounds and Injuries; Abdominal Injuries
• Other Study ID Numbers: Pro00112343

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No