Nutrition Ecosystem for Post-Abdominal Surgery
(PASTDUe Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Duke University
Disqualifiers: Diabetic ketoacidosis, Hepatic failure, others
No Placebo Group
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This trial tests a detailed nutrition plan for patients after major abdominal surgery. It includes specialized feeding, assessing nutritional requirements, and monitoring health to ensure proper nutrition.
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 study team or your doctor.
What data supports the effectiveness of the treatment Nutrition Ecosystem pathway, Total Parenteral Nutrition (TPN), Tube Feeding, and Oral Nutrition Supplements for post-abdominal surgery?
Research suggests that providing nutritional support, like TPN and tube feeding, before and after surgery can help reduce complications in malnourished patients. Enteral nutrition (feeding through the gut) is often as effective as TPN and may lead to fewer infections, making it a preferred option when possible.
12345Is the Nutrition Ecosystem treatment safe for humans?
Total Parenteral Nutrition (TPN) is generally considered safe for humans, though it was once thought to be risky. Studies show that TPN does not harm the gut lining or increase infection risk if not overused, and a ready-to-use TPN solution has been shown to be safe in postoperative patients.
36789How is the Nutrition Ecosystem pathway treatment different from other treatments for post-abdominal surgery?
The Nutrition Ecosystem pathway is unique because it combines Total Parenteral Nutrition (TPN), tube feeding, and oral nutrition supplements to support recovery after abdominal surgery. TPN provides nutrients directly into the bloodstream, bypassing the digestive system, which is beneficial for patients who cannot eat normally. This approach can improve immune function and promote healing, especially when enhanced with short-chain fatty acids.
4681011Eligibility Criteria
This trial is for adults over 18 who've had major abdominal surgery and are in the ICU, unable to eat normally for more than 72 hours. It's not for those with severe liver issues, prisoners, patients likely to die within 72 hours, pregnant or breastfeeding women, or those with certain diabetic conditions or allergies to nutrition solutions.Inclusion Criteria
Primary team approval of PN
Not expected to receive oral or enteral nutrition for > 72 hours
I had surgery less than 3 days ago.
+2 more
Exclusion Criteria
Patients allergic to any component of parenteral nutrition or lipid solution
I was hospitalized for severe diabetes complications.
Incarcerated or prisoner prior to admission
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive structured nutrition delivery via TPN, metabolic cart assessments, and oral nutrition supplements starting within 72 hours of surgery
Until hospital discharge
Indirect calorimetry and urine sample collection every 3 days during ICU stay, then every 5 days until discharge; BIA and muscle ultrasound every 7 days during ICU stay, then every 14 days until discharge
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests a structured nutrition plan using tube feeding and supplements against standard care in ICU patients after abdominal surgery. It includes measuring calorie needs through indirect calorimetry and tracking changes in body composition with non-invasive devices.
2Treatment groups
Experimental Treatment
Group I: Nutrition Ecosystem pathwayExperimental Treatment1 Intervention
1. parenteral nutrition initiated within 72 hours of operative intervention
2. metabolic cart assessments to determine resting energy expenditure (REE) and guide registered dietitians (RDs)
3. expedited delivery of oral nutrition supplements and
4. a team-based approach on proper documentation of nutrition delivery and intake.
Group II: ComparatorExperimental Treatment1 Intervention
300 historical matched control subjects not having received TPN in the first 7 hospital days will be enrolled from Duke Electronic Health Record between January 2018 and June 2020.
Nutrition Ecosystem pathway is already approved in United States for the following indications:
🇺🇸 Approved in United States as Nutrition Ecosystem pathway for:
- Nutritional support for patients in intensive care units (ICUs) post-abdominal surgery
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke University Medical CenterDurham, NC
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Who Is Running the Clinical Trial?
Duke UniversityLead Sponsor
References
The value of peri-operative nutrition in the sick patient. [2019]In summary, therefore, the provision of TPN to malnourished patients in the pre-operative period reduces the incidence of post-operative complications, but does not affect post-operative mortality. It is likely that the provision of nutrition by the enteral route is as effective as that by the parenteral route, and may have the extra benefit of resulting in a reduction in infectious complications when compared with patients receiving TPN. Furthermore, the use of enteral nutritional support in the post-operative period may also reduce both septic and major complications, but does not alter mortality. The use of specific combinations of nutrients appears to offer the greatest promise in the use of peri-operative nutritional support. The initial studies reported to date demonstrate reductions in post-operative morbidity, but again there are no benefits on mortality. However, further studies to determine the optimal combinations of nutrients for use in patients in the peri-operative period are urgently required.
[Respective indications of enteral or parenteral nutrition during pre- and post-operative periods]. [2019]Denutrition is often associated with poor postoperative outcome. However, a large body of evidence, from studies comparing perioperative parenteral (PN) or enteral (EN) nutrition to the absence of perioperative nutrition, suggests that perioperative nutritional support provides significant improvements in both nutritional status and postoperative clinical outcome in selected patients who are or will become malnourished. The aim of this study was to select and review all relevant articles comparing perioperative parenteral and enteral nutritional support, either in terms of clinical outcome, or risks and costs, or in pathophysiological terms. Twelve clinical reports were reviewed. All contained methodological flaws, mainly type II statistical error due to an insufficient number of patients, inaccurate primary diagnosis, absence of blinding, and lack of objective criteria of judgement. These concerns warrant caution in interpreting the results. Moderately strong (grade B) recommendations can only be drawn from these studies: PN (compared to early EN) is associated with a higher rate of sepsis in patients following abdominal trauma; EN is as efficient as PN in patients following surgery; EN is safe and cheaper than PN. PN formulae lack many important nutrients (glutamine, arginine, cysteine, peptides, fibers, n-3 polyunsaturated fatty acids, and nucleotides). Many experimental (animal) and some clinical (in non surgical patients) studies showed that PN (compared to EN) induces gut mucosal atrophy, liver dysfunction, gut bacterial translocation and immune dysfunction. The final aim of PN and EN would therefore strikingly differ. The qualitatively imperfect PN would only supply the fasting patient with quantitative amounts of calories and proteins. Due to initially limited digestive tolerance, EN provides less nutrition than PN does, but would finally lead to the same or even better outcome, due to its ability to counteract stress induced gut and immune dysfunction. Current evidence therefore suggests that early EN is superior to PN in trauma patients, and not different from but cheaper (and therefore more cost-effective) than PN in surgical patients. Further controlled, randomised, and blinded studies including sufficient sizes of groups are required, especially in the surgical setting, to address a large number of still unanswered questions.
Total parenteral nutrition: potion or poison? [2022]The role of nutritional support in clinical care has burgeoned over the past 40 y. Initially, total parenteral nutri-tion (TPN) was considered to be the standard of care. Later, the concept that enteral nutrition (EN) promoted gut function and prevented the translocation of intestinal bacteria resulted in EN becoming the standard of care. Furthermore, TPN was consid-ered to be a dangerous form of therapy. Critical review of the data suggests that, in humans, TPN does not cause mucosal atrophy or increase bacterial translocation. Increased sepsis with TPN can be ascribed to overfeeding; the dangers of TPN-induced complications have been exaggerated. TPN is an equally effective alternative to EN when a risk of malnutrition is present and EN is not tolerated or when gut failure is present.
Quick recovery of serum diamine oxidase activity in patients undergoing total gastrectomy by oral enteral nutrition. [2012]Total parental nutrition (TPN) meets the metabolic needs of postoperative patients, but introduces potential complications, including intestinal mucosal atrophy. Surgical advances have increased the certainty of esophagoenteric anastomosis making early oral enteral feeding after surgery feasible. The objective of the current report is to compare the benefits of enteral nutrition (EN) and TPN in patients undergoing total gastrectomy for gastric cancer.
Perioperative nutritional support. [2019]In selected malnourished patients, perioperative nutritional support can decrease the morbidity and mortality rates associated with major surgical procedures. Preoperative nutritional support should be delivered via the gastrointestinal tract whenever feasible, generally in the form of enteral diets, which can be given via a feeding tube or as a dietary supplement. Patients with a functional gut who cannot eat because of anorexia or upper gastrointestinal tract obstruction are candidates for preoperative tube feedings. Total parenteral nutrition should be the mainstay of nutritional support when the gastrointestinal tract cannot be used adequately. An improvement in nutritional indices (e.g., serum transferrin, lymphocyte count) may be associated with decreased perioperative morbidity, although the strength of this relation is not clear. In the absence of improvement in such indices, the duration of nutritional support required to decrease operative morbidity is unknown. Postoperatively, enteral tube feedings (delivered via a nasojejunal tube or feeding jejunostomy) should be provided to all preoperatively malnourished patients with a functional gastrointestinal tract who are unable to consume adequate calories orally. Postoperative TPN should be reserved for malnourished patients with a nonfunctional gut or for patients who develop a postoperative complication that precludes enteral feeding. Current nutritional formulas have often neglected the metabolic and nutritional requirements of the intestinal tract. In the future, the combined use of specific nutrients and growth factors may improve nutritional rehabilitation in catabolic patients.
Short-chain fatty acid-supplemented total parenteral nutrition improves nonspecific immunity after intestinal resection in rats. [2017]Total parenteral nutrition (TPN) alters both specific and nonspecific immune functions, resulting in immunosuppression. Short-chain fatty acids have been shown to improve the adaptive responses of the gut after surgery. The following study investigates the effects of adding short-chain fatty acids to TPN on the immune system after an 80% small bowel resection.
[Simple, safe postoperative parenteral nutrition with a ready-to-use all-in-one solution]. [2013]A newly developed, stable and ready-to-use industrially manufactured all-in-one solution for parenteral nutrition, containing amino acids, fat, glucose, xylitol and electrolytes, was tested in a prospective trial involving 21 patients from the 2nd to the 8th postoperative day. No side effects requiring interruption of the nutritional regimen, a positive nitrogen balance and a documented metabolic steady state proved that this solution is a safe therapeutic concept with respect to the typical postoperative metabolism. The all-in-one Vacu-Mix system is easy to handle, reduces the possibility of technical error and ensures safe and constant TPN administration.
Selective growth of mucolytic bacteria including Clostridium perfringens in a neonatal piglet model of total parenteral nutrition. [2022]Compromised barrier function and intestinal inflammation are common complications of total parenteral nutrition (TPN).
Intralipid-based short-term total parenteral nutrition does not impair small intestinal mucosa-related cellular immune reactivity in the healthy rat. [2017]The lipid component of total parenteral nutrition (TPN) has reportedly been associated with trophic effects on the intestinal mucosa and suppressive effects on the immune system.
Clinical-pharmacological aspects, application and effectiveness of total parenteral nutrition in surgical patients. [2013]The term "total parenteral nutrition" (TPN) refers to the maintenance of an adequate nutritional status, normal body weight and positive nitrogen balance solely by intravenous means. It requires solutions providing calories, amino acids and other nutrients in amounts much greater than those indicated for maintenance of normal body weight. Nutrient solutions have been studied, selected and prepared in our Hospital Pharmacological Service utilizing a sterile closed system, which allows large-volume filtering, sterilizing and bottling devices. For maintenance of weight gain in adults, a basic formula is employed, which provides 1,100 Kcal/1 with pure crystalline amino acids mixed with 50% anhydrous dextrose in water in a ratio of 5.8:1 (160 Kcal:1 g nitrogen). Minerals and vitamins are added to the base solution prior to use and may be increased or decreased by simple addition or omission depending on the patient's condition. This paper is based on 192 surgical patients who received TPN and have been followed in strict cooperation between the Hospital Pharmacological Service and the Surgical Department. The patients, ranging from 23 to 79 years of age, with life threatening diseases and unable to maintain adequate nutrition by the oral route, received TPN through a central catheter inserted via subclavian puncture (146 cases) or through a surgically created internal A-V fistula (46 cases). The condition of the patients generally improved within a few days after starting TPN; and weight gain, wound healing, general improvement and a shorter period of hospitalization were observed. TPN could be efficiently combined with oncologic treatment, and a significant improvement of the patients' performance status and decrease of toxic side-effects due to chemotherapeutic agents were observed. TPN has been successfully applied also in patients with fistulas of the alimentary tract obtaining spontaneous closure and in patients with ulcerative colitis, showing its beneficial effect in allowing complete bowel rest for healing. No major complications or deaths could be attributed to TPN or to the route of administration.
[Parenteral nutrition "à la carte" in major abdominal surgery with mixtures of Totamine concentrate and Vintène. A clinical study based on nitrogen balance]. [2013]The authors present a series of thirty patients who underwent major abdominal surgery. Each patient received preoperative total parenteral nutrition (TPN) during bowel preparation. After the operation the TPN was continued immediately, even if reanimation was necessary. The dosages of nitrogen and calories were individually adapted in function of the daily calculated nitrogen-balances. So the authors were able to administer a TPN "à la carte" using eight solutions mixed in a single bag, containing amino-acids (varying between 6 and 20 g of nitrogen), glucose (ad 150 Kcal/gN) lipids (constituting 40% of the calorie-intake), ions, vitamins and oligoelements. With a follow-up of minimum 10 days, the study proves the possibility of creating positive nitrogen-balances in 87% of the cases and an acceptable deviation in the daily measured glycemia and plasma-ionograms.