Nutrition Supplements for Abdominal Trauma Recovery
(SeND Home Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment SeND Home pathway, Structured Nutrition Delivery Plan, SeND Home Program for abdominal trauma recovery?
Research shows that structured nutrition plans and early nutrition delivery can improve recovery outcomes in patients after surgery, including reduced complications and shorter hospital stays. These findings suggest that a structured nutrition delivery plan like the SeND Home Program could be beneficial for abdominal trauma recovery.12345
Is the SeND Home pathway or similar nutrition supplement programs safe for human use?
How is the SeND Home treatment different from other treatments for abdominal trauma recovery?
The SeND Home treatment is unique because it uses a structured nutrition delivery plan that includes specific nutrients known to enhance immune function and reduce complications after trauma. Unlike other treatments, it focuses on enteral (through the digestive tract) nutrition with supplements like glutamine, arginine, and omega-3 fatty acids, which have been shown to improve recovery by reducing infections and hospital stays.310111213
Research Team
Paul Wischmeyer, MD
Principal Investigator
Duke
Eligibility Criteria
This trial is for adults who've had emergency abdominal surgery due to trauma and are in the ICU, unable to eat normally for at least 72 hours. It's not suitable for those who can't walk, may have life support withdrawn within two days, prisoners, or pregnant women.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive total parenteral nutrition (TPN) within 72 hours of abdominal surgery, followed by oral nutrition supplements for 4 weeks after discharge
Follow-up
Participants are monitored for changes in muscle strength, physical function, and quality of life at various intervals
Treatment Details
Interventions
- SeND Home pathway
SeND Home pathway is already approved in United States for the following indications:
- Nutritional support for trauma patients in intensive care units
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
United States Department of Defense
Collaborator
Baxter Healthcare Corporation
Industry Sponsor
Dr. Heather Knight
Baxter Healthcare Corporation
Chief Medical Officer
MD
Brent Shafer
Baxter Healthcare Corporation
Chief Executive Officer
Bachelor's degree in Business Administration