150 Participants Needed

Nutrition Supplements for Abdominal Trauma Recovery

(SeND Home Trial)

KH
SH
Overseen ByShauna Howell
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Duke University
Must be taking: Total parenteral nutrition
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

Research on home enteral nutrition programs, which are similar to the SeND Home pathway, shows that they are generally safe, with a low rate of complications (0.07 episodes per patient-year) and effective in maintaining nutrition status and quality of life.56789

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

PW

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

I am currently in the surgical intensive care unit.
I am 18 years old or older.
I needed emergency surgery due to a severe injury to my abdomen.
See 1 more

Exclusion Criteria

Expected withdrawal of life-sustaining treatment within 48 hours
I cannot walk by myself.
Prisoners
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive total parenteral nutrition (TPN) within 72 hours of abdominal surgery, followed by oral nutrition supplements for 4 weeks after discharge

4 weeks
Daily visits during hospital stay, weekly follow-up visits post-discharge

Follow-up

Participants are monitored for changes in muscle strength, physical function, and quality of life at various intervals

6 months
Visits at hospital discharge, 3 months, and 6 months post-discharge

Treatment Details

Interventions

  • SeND Home pathway
Trial OverviewThe study tests a personalized nutrition plan (SeND Home pathway) involving TPN and oral supplements against standard care. Participants will be randomly assigned to either receive SeND Home with follow-up after hospital discharge or just the usual hospital care.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: SeND Home PathwayExperimental Treatment1 Intervention
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.
Group II: Standard NutritionActive Control1 Intervention
Standard nutrition as determined by clinical providers.

SeND Home pathway is already approved in United States for the following indications:

🇺🇸
Approved in United States as SeND Home pathway for:
  • Nutritional support for trauma patients in intensive care units

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Baxter Healthcare Corporation

Industry Sponsor

Trials
328
Recruited
203,000+
Dr. Heather Knight profile image

Dr. Heather Knight

Baxter Healthcare Corporation

Chief Medical Officer

MD

Brent Shafer profile image

Brent Shafer

Baxter Healthcare Corporation

Chief Executive Officer

Bachelor's degree in Business Administration

Findings from Research

The implementation of an evidence-based nutrition enhancement protocol (EP) significantly improved the delivery of enteral nutrition (EN) in critically ill trauma and surgical patients, increasing the average percentage of nutrition delivered from 75.3% to 85.5%.
The percentage of patients receiving more than 80% of their nutrition goals also rose from 52.7% to 65.2%, demonstrating that the EP aligns with national guidelines and effectively supports better nutritional outcomes in the ICU.
Improving enteral nutrition delivery in the critically ill trauma and surgical population.McCartt, J., Loszko, A., Backes, K., et al.[2022]
Nutritional supplementation after gastrointestinal surgery is safe and can increase energy and protein intake, as well as weight, particularly in malnourished patients, based on a systematic review of four studies.
However, there is limited evidence that these supplements significantly reduce clinical complications or improve quality of life, fatigue, or hand grip strength, indicating a need for more robust studies to assess their overall effectiveness.
Systematic review of postdischarge oral nutritional supplementation in patients undergoing GI surgery.Lidder, PG., Lewis, S., Duxbury, M., et al.[2018]
The implementation of an evidence-based nutrition care pathway for 40 lower gastrointestinal and pelvic cancer patients significantly increased the proportion of patients receiving dietetic assessment and education before and after surgery, improving adherence to nutritional care.
While the pathway led to a reduction in mean weight loss during hospitalization (-3.5% vs -5.6%), the post-operative length of stay remained unchanged, indicating that the pathway effectively supported nutritional care without affecting recovery time.
Effect of an Evidence-Based Nutrition Care Pathway for Cancer Patients Undergoing Gastrointestinal and Pelvic Surgery.Den, E., Steer, B., Quinn, P., et al.[2022]

References

Improving enteral nutrition delivery in the critically ill trauma and surgical population. [2022]
Systematic review of postdischarge oral nutritional supplementation in patients undergoing GI surgery. [2018]
Effect of an Evidence-Based Nutrition Care Pathway for Cancer Patients Undergoing Gastrointestinal and Pelvic Surgery. [2022]
Introduction of guidelines to facilitate enteral nutrition in a surgical intensive care unit is associated with earlier enteral feeding. [2018]
Ordering a Normal Diet at the End of Surgery-Justified or Overhasty? [2019]
Bilateral Exchange: Enteral Nutrition Clinical Decision Making in Pediatric Surgery Patients. [2023]
[Are Doctors familiar with enteral nutrition at home? Opinion poll in the province of Tarragona]. [2015]
[Domiciliary artificial nutrition. Annual Report 1994. NADYA Group]. [2013]
A telephone support program for patients with home enteral nutrition contributes to nutrition status and quality of life maintenance and reduces health resource use. [2022]
Rational base and clinical results of immunonutrition. [2015]
11.United Statespubmed.ncbi.nlm.nih.gov
The route of nutrition support affects the early phase of wound healing. [2017]
Clinical benefits of early post-injury enteral feeding. [2007]
Early enteral gut feeding with conditionally indispensable pharmaconutrients is metabolically safe and is well tolerated in postoperative cancer patients--a pilot study. [2013]