Nutrition Supplements for Abdominal Trauma Recovery
(SeND Home Trial)
Recruiting in Palo Alto (17 mi)
Overseen byPaul Wischmeyer, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Duke University
Must be taking: Total parenteral nutrition
Disqualifiers: Non-ambulatory, Life-sustaining withdrawal, Pregnancy, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
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.
12345Is 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.
56789How 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.
310111213Eligibility 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.
+1 more
Exclusion Criteria
Expected withdrawal of life-sustaining treatment within 48 hours
I cannot walk by myself.
Prisoners
+1 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Duke University HospitalDurham, NC
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Who Is Running the Clinical Trial?
Duke UniversityLead Sponsor
United States Department of DefenseCollaborator
Baxter Healthcare CorporationIndustry Sponsor
References
Improving enteral nutrition delivery in the critically ill trauma and surgical population. [2022]Critically ill trauma and surgical patients often fail to achieve adequate enteral nutrition (EN) support. We hypothesize that implementation of an evidence-based, multidisciplinary nutrition enhancement protocol (EP) will improve delivery of EN in critically ill trauma and surgical patients and align our institution with nationally recommended guidelines.
Systematic review of postdischarge oral nutritional supplementation in patients undergoing GI surgery. [2018]To determine whether nutritional supplementation following hospital discharge in patients who undergo gastrointestinal (GI) surgery is beneficial in specific outcome measures.
Effect of an Evidence-Based Nutrition Care Pathway for Cancer Patients Undergoing Gastrointestinal and Pelvic Surgery. [2022]Malnutrition in gastrointestinal surgery is associated with poorer post-operative outcomes which may be mitigated by delivery of evidence-based nutrition care. This study reports on the development, implementation and evaluation of an evidence-based nutrition care pathway for lower gastrointestinal and pelvic cancer patients. A retrospective cohort study of 40 surgical lower gastrointestinal and pelvic cancer patients pre- and post-implementation of the pathway was conducted. Outcomes assessed were, care pathway adherence, weight change, time to post-operative commencement of nutrition, and post-operative length of stay. Post-implementation of the pathway there were significant improvements in the proportion of patients who received dietetic assessment and education pre-surgery (0% vs 55%, P < .001) at regular intervals during admission (35% vs. 90%, P < .001) and post-discharge (22.5% vs. 81.8%, P < .001). Mean weight change between admission and discharge reduced post-implementation (-3.5%, SD 4.7 vs, -5.6%, SD 4.7; P = 0.08). Post-operative length of stay remained similar (16 day, IQR 11-34.7 vs. 17.5 day, IQR 11.2-25; P = 0.71). Post-implementation a greater proportion of patients commenced oral or enteral nutrition within 24 h, post-operatively (75% vs. 57.5%, P = 0.1). The nutrition care pathway was an effective method for delivering evidence-based nutrition care, resulting in clinically but not statistically significant improvements in outcomes.
Introduction of guidelines to facilitate enteral nutrition in a surgical intensive care unit is associated with earlier enteral feeding. [2018]Patients treated postoperatively in surgical intensive care units often receive delayed enteral nutrition. We hypothesized that the introduction of guidelines promoting early enteral nutrition is associated with earlier enteral feeding.
Ordering a Normal Diet at the End of Surgery-Justified or Overhasty? [2019]Early re-alimentation is advocated by enhanced recovery pathways (ERP). This study aimed to assess compliance to ERP-set early re-alimentation policy and to compare outcomes of early fed patients and patients in whom early feeding was withhold due to the independent decision making of the surgeon. For this purpose, demographic, surgical and outcome data of all consecutive elective colorectal surgical procedures (2011⁻2016) were retrieved from a prospectively maintained institutional ERP database. The primary endpoint was postoperative ileus (POI). Surgical 30-day outcome and length of stay were compared between patients undergoing the pathway-intended early re-alimentation pattern and patients in whom early re-alimentation was not compliant. Out of the 7103 patients included, 1241 (17.4%) were not compliant with ERP re-alimentation. Patients with delayed re-alimentation presented with more postoperative complications (37 vs. 21%, p < 0.001) and a prolonged length of hospital stay (8 ± 7 vs. 5 ± 4 days, p < 0.001). While male gender (odds ratio (OR) 1.24; 95% confidence interval (CI) 1.04⁻1.32), fluid overload (OR 1.38; 95% CI 1.16⁻1.65) and high American Society of Anaesthesiologists (ASA) score (OR 1.51; 95% CI 1.27⁻1.8) were independent risk factors for POI, laparoscopy (OR 0.51; 95% CI 0.38⁻0.68) and ERP compliant diet (OR 0.46; 95% CI 0.36⁻0.6) were both protective. Hence, this study provides further evidence of the beneficial effect of early oral feeding after colorectal surgery.
Bilateral Exchange: Enteral Nutrition Clinical Decision Making in Pediatric Surgery Patients. [2023]Evidence-based medicine guides clinical decision-making; however, promoting enteral nutrition has historically followed a dogmatic approach in which patients graduate from clear liquids to full liquids to a regular diet after return of bowel function. Enhanced recovery after surgery has demonstrated that early enteral nutrition initiation is associated with shorter hospital stays. We aimed to understand postoperative pediatric nutrition practices in Kenya and the United States.
[Are Doctors familiar with enteral nutrition at home? Opinion poll in the province of Tarragona]. [2015]At our hospital, there is an At-Home Enteral Nutrition programme (NED in its Spanish acronym) with participation of the Clinical Nutrition Unit and the Pharmacy Service. The products and all necessary material are dispensed directly to the patient's home and nutritional follow-up is carried out. As a lack of information on various aspects of NED was detected among prescribing doctors, we decided to carry out a survey to assess the level of awareness and the opinion of doctors in the province of Tarragona with regard to NED. They were asked if they knew the indications and characteristics of the different enteral nutrition preparations, as well as their opinion on who should do the follow-up of the patients and on how dispensation should be organized. With the results obtained, we conclude that doctors rarely prescribe NED and are not familiar with the indications nor with enteral nutrition preparations (77.5% and 89%, respectively), although they are interested in the subject. They feel that dispensation should be done directly at the patient's home (43%) and that follow-up should be through a specialized team (57.6%).
[Domiciliary artificial nutrition. Annual Report 1994. NADYA Group]. [2013]The NADYA Group, integrated in the Spanish Society of Parenteral and Enteral Nutrition (SENPE), and made up of professionals dedicated to Artificial Nutrition, and specifically, to Artificial Nutrition in the home, annually undertakes the task of collecting data on diagnosis, type of support, follow up characteristics, complications, and quality of life, of patients included in programs of at home artificial nutrition in Spain. In the Annual Register corresponding to 1994, 17 hospitality groups have participated, providing 369 patients with Home Enteral Nutrition, and 30 with Home Parenteral Nutrition. Home Enteral Nutrition is mainly applied in patients with neoplasias (36%) or neurological alterations (35%). The most commonly used access route in the nasogastric tube, although there is an observed increase in the application of Percutaneous Gastrostomies (21%) in relation to previous data of the Spanish population. There is an observed complications index of 0.07 episodes/patient-year, a mortality of 30% (neoplasias) and 20% (neurological alterations), and low rehabilitation indexes in this group. In Home Parenteral Nutrition, post-radiation enteritis, neoplasias, and mesenteric ischemia, are the main diagnostic groups. The majority of the patients have a tunneled tube (63%), with 37% using an implanted tube. With an index of hospitalizations of 0.83 hospitalizations/ patient-year, catheter septicemia justifies the majority of the re-hospitalizations derived from nutritional treatment (0.56 hospitalizations/patient-year), note the mortality of 37%. There are complete rehabilitations, continuing the previously normal activity in 80% of the cases.
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]Appropriate patient/caregiver training and continuity of care after hospital discharge are key factors for the success of home enteral nutrition (HEN). This study aims to assess the effects of a specific patient support program (PSP) on the nutrition status, health-related quality of life (HRQoL), and healthcare resource utilization and associated costs of patients with HEN.
Rational base and clinical results of immunonutrition. [2015]The use of enteral formulas supplemented with immunonutrients has been demonstrated to modulate gut function, inflammatory and immune response after trauma in both experimental and clinical settings. Most studies have focused on glutamine, arginine, w-3 fatty acids and nucleotides. Glutamine is an important source of nitrogen and calories and might be particularly useful in depleted patients or in patients affected by small bowel syndrome. Its use in the critical patient remains controversial. Data collected in two different recent metaanalysis consistently confirmed that enteral formulas enriched with, arginine, w-3 fatty acids and nucleotides reduced infectious complications and hospital stay after planned surgery, and decreased infectious complications, hospital stay and ventilator days in the critically ill. Mortality seems not to be affected by enteral administration of immunonutrients.
The route of nutrition support affects the early phase of wound healing. [2017]Nutrition support via the enteral route has been shown to be superior to parenteral administration in maintaining immune function, decreasing septic complications, and increasing survival after severe trauma and surgical injury. Whether the route of nutrition support affects wound healing, another important determinant of outcome following injury, is not known.
Clinical benefits of early post-injury enteral feeding. [2007]Over the past two decades, clinical studies have provided convincing evidence that early nutritional support benefits metabolically stressed surgical patients by preventing acute protein malnutrition. However, the optimal route of substrate delivery (ie, enteral versus parenteral) continues to be debated. Recent basic and clinical investigation offers the exciting possibility that the beneficial effects of traditional nutritional support can be amplified by supplementing specific nutrients that exert pharmacological immune-enhancing effects. Over the past 15 years, the Department of Surgery at the Denver General Hospital has focused clinical research efforts on defining optimal nutrition following major torso trauma. The purpose of this paper is to review our studies as well as other clinical studies in order to answer three questions: 1) Does early post-injury nutritional support improve patient outcome? 2) What is the preferred route of substrate delivery? 3) Do new 'immune-enhancing' diets offer additional clinical benefits?
Early enteral gut feeding with conditionally indispensable pharmaconutrients is metabolically safe and is well tolerated in postoperative cancer patients--a pilot study. [2013]Postoperative early enteral gut feeding with conditionally indispensable pharmaconutrients can contribute to minimize trauma-induced gut damage. Aim of this pilot study was the evaluation of metabolic effects and gastrointestinal tolerance of a new enteral supplement.