Nutrition Supplements for Abdominal Trauma Recovery

(SeND Home Trial)

Overseen By Hilary Winthrop

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Duke University

Must be taking: Total parenteral nutrition

Disqualifiers: Non-ambulatory, Life-sustaining withdrawal, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering nutrition to ICU patients who have undergone emergency abdominal surgery after trauma. The study aims to determine if the SeND Home pathway (Structured Nutrition Delivery Plan), which combines nutrition through the bloodstream and shakes, improves recovery compared to standard nutrition practices. Participants will be divided into two groups: one will follow the SeND Home pathway, while the other will receive usual care. Ideal candidates for the trial are those with a serious abdominal injury who required surgery and are not expected to eat normally for at least three days. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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 prior data suggests that the SeND Home pathway is safe for abdominal trauma recovery?

Research has shown that providing nutrition directly into the bloodstream, known as parenteral nutrition (PN), can be done safely without increasing risks. This is crucial when eating by mouth isn't possible soon after surgery. Studies indicate that personalized nutrition plans, such as the SeND Home pathway, aim to deliver nutrition safely. The process starts with PN and then includes shakes once a patient can drink liquids.

For those concerned about safety, early results from similar programs suggest they are well-tolerated. Specifically, patients in previous studies did not experience a higher risk of side effects with personalized nutrition plans. This suggests the SeND Home pathway is likely safe, but more information from ongoing studies will provide clearer answers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SeND Home pathway because it offers a tailored nutrition approach for patients recovering from abdominal trauma. Unlike standard post-surgery nutrition, which relies on a one-size-fits-all diet, this pathway uses indirect calorimetry to determine precise calorie needs and begins total parenteral nutrition (TPN) within 72 hours of surgery. This personalized method aims to enhance recovery by providing the exact nutrients required at critical times, potentially speeding up healing and improving overall outcomes. Additionally, the integration of nutritional shakes as part of a liquid diet both in the hospital and at home for four weeks is designed to offer continuous support during the crucial recovery phase.

What evidence suggests that the SeND Home pathway is effective for abdominal trauma recovery?

Research has shown that the SeND Home pathway, a planned nutrition delivery system, holds promise for patients recovering from abdominal injuries. In this trial, participants in the SeND Home Pathway arm will receive personalized nutrition, including both intravenous nutrition (TPN) and oral nutrition supplements. Studies have found that such personalized nutrition can help reduce complications and improve recovery rates. Specifically, a structured plan like SeND Home resulted in lower death rates and fewer complications within 30 days of treatment. Tools like indirect calorimetry, which measures how many calories a person needs, ensure patients receive the right amount of nutrition, crucial for recovery. Overall, personalized nutrition plans like SeND Home offer significant benefits for trauma patients in critical care. ^{1 2 3 4 6}

Who Is on the Research Team?

Paul Wischmeyer, MD

Principal Investigator

Duke

Are You a Good Fit for This Trial?

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 needed emergency surgery due to a severe injury to my abdomen.

You are not anticipated to be nourished orally for a period of 72 hours or longer.

Exclusion Criteria

Expected withdrawal of life-sustaining treatment within 48 hours

I cannot walk by myself.

Prisoners

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• SeND Home pathway

Trial Overview The 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.

How Is the Trial Designed?

Group I: SeND Home Pathway Experimental Treatment 1 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 Nutrition Active Control 1 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

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

Baxter Healthcare Corporation

Chief Medical Officer

MD

Brent Shafer

Baxter Healthcare Corporation

Chief Executive Officer

Bachelor's degree in Business Administration

Published Research Related to This Trial

Enteral formulas enriched with immunonutrients like arginine, w-3 fatty acids, and nucleotides have been shown to reduce infectious complications and shorten hospital stays in both surgical and critically ill patients, based on recent meta-analyses.

While glutamine is beneficial for certain patients, its role in critical care remains debated, and overall, the use of immunonutrients does not appear to impact mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rational base and clinical results of immunonutrition. Gentilini, O., Braga, M., Gianotti, L.[2015]

Enteral nutrition significantly improves wound breaking strength and collagen accumulation in the early phases of healing compared to parenteral nutrition, as shown in a study with 49 rats.

The benefits of enteral feeding on wound healing were observed on day 5 post-surgery, but no differences were noted at later time points (days 7 and 10), indicating that the advantages are limited to the initial healing stages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The route of nutrition support affects the early phase of wound healing. Kiyama, T., Witte, MB., Thornton, FJ., et al.[2017]

Early nutritional support is crucial for metabolically stressed surgical patients, as it helps prevent acute protein malnutrition and improves patient outcomes after major torso trauma.

The debate continues over the best method of delivering nutrition (enteral vs. parenteral), and recent studies suggest that adding specific immune-enhancing nutrients could further improve clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical benefits of early post-injury enteral feeding. Moore, FA., Moore, EE., Haenel, JB.[2007]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The pilot study involving 20 cancer patients demonstrated that early postoperative enteral feeding with a new supplement was well tolerated, with no adverse events reported, indicating its safety for use after gastrointestinal surgery.

Significant increases in plasma levels of key nutrients such as vitamin C, vitamin E, zinc, selenium, and glutamine were observed, suggesting effective absorption and potential metabolic benefits from the supplement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early enteral gut feeding with conditionally indispensable pharmaconutrients is metabolically safe and is well tolerated in postoperative cancer patients--a pilot study. Senkal, M., Haaker, R., Deska, T., et al.[2013]

In a study of 7103 elective colorectal surgery patients, those who followed the early re-alimentation policy had significantly fewer postoperative complications and shorter hospital stays compared to those who did not comply, highlighting the benefits of early feeding.

The research identified that compliance with early feeding reduced the risk of postoperative ileus, with factors like laparoscopic surgery and adherence to the early re-alimentation pathway being protective against complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ordering a Normal Diet at the End of Surgery-Justified or Overhasty? Grass, F., Hübner, M., Lovely, JK., et al.[2019]

A study of 75 pediatric patients in Kenya and the United States revealed that early initiation of enteral nutrition is associated with shorter hospital stays, supporting the idea that traditional feeding protocols may need to be revised.

In particular, while Kenyan neonates started enteral nutrition sooner than their U.S. counterparts, their overall hospital stays were not significantly different, suggesting that tailored nutrition protocols could improve outcomes in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral Exchange: Enteral Nutrition Clinical Decision Making in Pediatric Surgery Patients. Bhatia, MB., Anderson, CM., Hussein, AN., et al.[2023]

A survey of doctors in Tarragona revealed that 77.5% are not familiar with the indications for At-Home Enteral Nutrition (NED), and 89% lack knowledge about different enteral nutrition preparations, indicating a significant gap in awareness.

Despite their limited knowledge, doctors expressed a preference for home delivery of nutrition products (43%) and believe that patient follow-up should be managed by a specialized team (57.6%), highlighting the need for better education and support in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Are Doctors familiar with enteral nutrition at home? Opinion poll in the province of Tarragona]. Bonada, A., Gómez-Gener, A., Boj, M., et al.[2015]

In a study involving 369 patients receiving Home Enteral Nutrition and 30 patients receiving Home Parenteral Nutrition, it was found that Home Enteral Nutrition is primarily used for patients with neoplasias (36%) and neurological disorders (35%), with a low complication rate of 0.07 episodes per patient per year.

Home Parenteral Nutrition showed a higher hospitalization rate of 0.83 hospitalizations per patient per year, mainly due to catheter-related infections, and a mortality rate of 37%, but 80% of patients experienced complete rehabilitation and returned to normal activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Domiciliary artificial nutrition. Annual Report 1994. NADYA Group]. Gómez Candela, C., de Cos, AI.[2013]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of postdischarge oral nutritional supplementation in patients undergoing GI surgery. Lidder, PG., Lewis, S., Duxbury, M., et al.[2018]

The implementation of new guidelines for enteral nutrition in a surgical intensive care unit led to a significant reduction in the time to start enteral feeding, with a median of 1 day compared to 2 days before the guidelines were introduced (p < 0.001).

There was no increase in aspiration events or adverse effects associated with earlier enteral feeding, indicating that the guidelines improved nutritional support without compromising patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction of guidelines to facilitate enteral nutrition in a surgical intensive care unit is associated with earlier enteral feeding. Zacharias, N., Blank, R., Bittner, EA., et al.[2018]

A patient support program (PSP) for home enteral nutrition (HEN) helped maintain patients' nutrition status and health-related quality of life (HRQoL) over a 6-month period, with no significant changes in scores from baseline.

The PSP also led to a reduction in unplanned healthcare resource utilization, resulting in cost savings of approximately €1518 (US $1356) due to fewer emergency visits, highlighting the program's efficacy in improving care continuity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A telephone support program for patients with home enteral nutrition contributes to nutrition status and quality of life maintenance and reduces health resource use. Cantón Blanco, A., López Osorio, N., Gómez Vázquez, E., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving enteral nutrition delivery in the critically ill trauma and surgical population. McCartt, J., Loszko, A., Backes, K., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06065202

Personalized Nutrition to Improve Recovery in Trauma ... In the SeND Home program, participants will receive TPN, followed by oral nutrition supplements (shakes) for 4 weeks after discharge. The control group will ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10318839/

Personalized nutrition therapy in critical care: 10 expert ... The structured algorithm led to significant reductions in mortality and complications at 30 days, and significant improvement in recovery/ ...

3. apps.dtic.mil apps.dtic.mil/sti/html/trecms/AD1213970/index.html

Personalized Targeted Nutrition via StructurEd ... - DTIC SeND Home offers a personalized early parenteral nutrition (PN) regimen, drawing on data from the LEEP-COVID study and aligning with international ICU ...

4. aspenjournals.onlinelibrary.wiley.com aspenjournals.onlinelibrary.wiley.com/doi/full/10.1002/jpen.2733

Nutrition and Metabolism Research Oral Paper Session ... Results: The use of an EMG device to place tubes improves nutrition delivery by reducing the time to place and replace a feeding tube. From the ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2161831324001856

Nutritional Optimization of the Surgical Patient: A Narrative ... The physiologic insult caused by trauma is significant, and energy expenditure has been shown to be 20%–50% greater in trauma patients compared with those ...

6. apps.dtic.mil apps.dtic.mil/sti/trecms/pdf/AD1213970.pdf

Table of Contents - DTIC The proposed SeND Home program is designed to optimize nutrition through personalized caloric requirements, early identification of protein- ...