Nutrition Ecosystem for Post-Abdominal Surgery

(PASTDUe Trial)

Overseen By Paul E. Wischmeyer, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Duke University

Disqualifiers: Diabetic ketoacidosis, Hepatic failure, 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: Until hospital discharge

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special nutrition plan, the Nutrition Ecosystem pathway, aids ICU patients in recovering better after abdominal surgery. The plan includes various nutrition delivery methods, such as tube feeding and a device to assess calorie needs. The study will also monitor changes in fat and muscle during the hospital stay. Individuals who have undergone major abdominal surgery and cannot eat normally for more than three days may be suitable candidates for this trial. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for the Nutrition Ecosystem pathway?

Research has shown that total parenteral nutrition (TPN), which delivers nutrition directly into the bloodstream, is safe for patients. It often treats malnutrition and helps reduce complications after surgery. Past studies found TPN to be generally well-tolerated, with most people not experiencing serious side effects.

The devices used in this study, such as the indirect calorimeter for measuring calorie needs and bioelectrical impedance analysis (BIA) for assessing body fat and muscle, are also safe. They are non-invasive, meaning they do not involve surgery or entering the body, and have received FDA approval, indicating they meet safety standards for use in people.

Overall, the treatments and methods tested have a strong safety record. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Nutrition Ecosystem pathway because it offers a more integrated and timely approach to post-abdominal surgery recovery. Unlike traditional care, which may delay nutritional support, this protocol initiates parenteral nutrition within 72 hours, potentially speeding up recovery. It also uses metabolic cart assessments to tailor nutritional needs precisely, and the team-based strategy ensures meticulous documentation and delivery of nutrition. This approach could optimize healing and improve patient outcomes more effectively than standard protocols.

What evidence suggests that the Nutrition Ecosystem pathway is effective for improving outcomes after abdominal surgery?

Research has shown that total parenteral nutrition (TPN), which delivers nutrition through an IV, can reduce the risk of complications in malnourished patients before surgery. Eating by mouth soon after surgery can also speed up recovery and shorten hospital stays. Studies indicate that tube feeding, known as enteral nutrition, is effective and may result in fewer infections compared to TPN alone. Additionally, TPN before surgery has been linked to weight gain, improved nutrition, and reduced inflammation. This trial will evaluate the Nutrition Ecosystem pathway, which includes early parenteral nutrition, metabolic assessments, and expedited oral nutrition supplements, against a comparator group. Overall, these findings suggest that structured nutrition plans, like the Nutrition Ecosystem pathway, could improve patient outcomes after surgery. ^{1 3 6 7 8}

Who Is on the Research Team?

Paul Wischmeyer

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Nutrition Ecosystem pathway

Trial Overview 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.

How Is the Trial Designed?

Group I: Nutrition Ecosystem pathway Experimental Treatment 1 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: Comparator Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

Total parenteral nutrition (TPN) has been shown to significantly improve the nutritional status and overall condition of 192 surgical patients, leading to weight gain, wound healing, and shorter hospital stays.

TPN can be safely administered through central catheters and has been effective in patients with life-threatening conditions, showing no major complications or deaths related to its use, while also enhancing the effectiveness of oncologic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical-pharmacological aspects, application and effectiveness of total parenteral nutrition in surgical patients. Dionigi, R., Guaglio, R., Bonera, A., et al.[2013]

Total parenteral nutrition (TPN) is now recognized as a safe and effective alternative to enteral nutrition (EN) in cases where patients cannot tolerate EN or have gut failure, despite previous concerns about its safety.

Recent reviews indicate that TPN does not cause mucosal atrophy or increase the risk of bacterial translocation, and complications associated with TPN are often due to overfeeding rather than the therapy itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total parenteral nutrition: potion or poison? Jeejeebhoy, KN.[2022]

In a study using healthy rodents over 7 days, both lipid-based and carbohydrate-based total parenteral nutrition (TPN) resulted in limited mucosal atrophy, with preserved intestinal surface architecture compared to enteral feeding.

Despite some differences in mucosal enzyme activity and weight gain, both TPN regimens did not impair the cellular immune response, indicating that neither lipid nor carbohydrate-based TPN negatively affects immune function in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intralipid-based short-term total parenteral nutrition does not impair small intestinal mucosa-related cellular immune reactivity in the healthy rat. Gross, T., Babst, R., Juretic, A., et al.[2017]

In a study of 30 patients undergoing major abdominal surgery, preoperative total parenteral nutrition (TPN) was effectively used to create positive nitrogen balances in 87% of cases, indicating its efficacy in supporting recovery.

The individualized TPN approach, which included tailored dosages of amino acids, glucose, and lipids, resulted in acceptable control of blood sugar and plasma ion levels during a minimum follow-up of 10 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Parenteral nutrition "à la carte" in major abdominal surgery with mixtures of Totamine concentrate and Vintène. A clinical study based on nitrogen balance]. Vanden Bavière, H., De Roose, J., Derom, F., et al.[2013]

Providing total parenteral nutrition (TPN) to malnourished patients before surgery reduces post-operative complications but does not impact mortality rates.

Enteral nutrition may be as effective as TPN and could lower the risk of infections, while specific nutrient combinations show promise in reducing post-operative complications, though more research is needed to identify the best nutrient strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of peri-operative nutrition in the sick patient. Heys, SD., Walker, LG., Eremin, O.[2019]

In a study comparing piglets fed total enteral nutrition (TEN) and total parenteral nutrition (TPN), TPN was found to select for bacteria, particularly Clostridium perfringens, that can degrade mucus, potentially compromising intestinal barrier function.

The research indicated that 62% of mucus-associated bacteria in TPN piglets could grow on mucin, compared to only 33% in TEN piglets, suggesting that the lack of enteral nutrients in TPN may lead to an increase in mucolytic bacteria, which could contribute to intestinal dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective growth of mucolytic bacteria including Clostridium perfringens in a neonatal piglet model of total parenteral nutrition. Deplancke, B., Vidal, O., Ganessunker, D., et al.[2022]

Enteral nutrition (EN) starting on postoperative day 3 after total gastrectomy for gastric cancer showed quicker recovery of intestinal mucosal integrity compared to total parental nutrition (TPN), as indicated by the faster recovery of diamine oxidase (DAO) activity in the EN group.

Patients receiving EN experienced shorter hospital stays and lower treatment costs compared to those on TPN, while both groups had similar complication rates, highlighting EN as a more efficient nutritional strategy post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quick recovery of serum diamine oxidase activity in patients undergoing total gastrectomy by oral enteral nutrition. Kamei, H., Hachisuka, T., Nakao, M., et al.[2012]

A new all-in-one parenteral nutrition solution was tested in a trial with 21 postoperative patients, showing no side effects that required stopping the treatment, indicating its safety for use.

The solution led to a positive nitrogen balance and maintained metabolic stability, demonstrating its efficacy in supporting postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Simple, safe postoperative parenteral nutrition with a ready-to-use all-in-one solution]. Leutenegger, A., Dillier, C.[2013]

Perioperative enteral nutrition (EN) is as effective as parenteral nutrition (PN) in surgical patients and is safer and more cost-effective, while PN is associated with a higher rate of sepsis in patients following abdominal trauma.

Current evidence suggests that early EN is superior to PN in trauma patients, as PN can lead to complications like gut mucosal atrophy and immune dysfunction, highlighting the need for more rigorous studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Respective indications of enteral or parenteral nutrition during pre- and post-operative periods]. Petit, J., Kaeffer, N., Déchelotte, P., et al.[2019]

Preoperative nutritional support, especially through enteral feeding, can significantly reduce morbidity and mortality in malnourished patients undergoing major surgery, highlighting the importance of addressing nutritional needs before operations.

Postoperative care should prioritize enteral feeding for patients with a functional gut, while total parenteral nutrition is reserved for those unable to use their gastrointestinal tract, indicating a tailored approach to nutritional support based on individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative nutritional support. Ellis, LM., Copeland, EM., Souba, WW.[2019]

Adding short-chain fatty acids to total parenteral nutrition (TPN) in rats after an 80% small bowel resection significantly enhanced the cytotoxic activity of natural killer cells compared to TPN alone, indicating a potential improvement in immune function.

The study suggests that short-chain fatty acids may help mitigate TPN-associated immunosuppression by positively affecting immune cell populations, particularly in the early days following surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-chain fatty acid-supplemented total parenteral nutrition improves nonspecific immunity after intestinal resection in rats. Pratt, VC., Tappenden, KA., McBurney, MI., et al.[2017]

Citations

1. withpower.com withpower.com/trial/phase-4-intraabdominal-infections-11-2021-6ae08

Nutrition Ecosystem for Post-Abdominal Surgery Providing total parenteral nutrition (TPN) to malnourished patients before surgery reduces post-operative complications but does not impact mortality rates.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3113258/

A Meta-Analysis of Enteral Nutrition and Total Parenteral ... This study demonstrated that enteral nutritional support is safe and effective when compared to parenteral support. Compared with TPN, EN was associated with a ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC293477/

Nutrition support to patients undergoing gastrointestinal surgery Meta-analyses have shown that enteral nutrition is associated with fewer septic complications compared with parenteral feeding, reduced costs and a shorter ...

4. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1369141/full

The effect of early oral postoperative feeding on ... This review suggests that early oral feeding after gastrointestinal surgery may lead to a faster intestinal recovery, shorter postoperative stays, and fewer ...

5. mdpi.com mdpi.com/2072-6643/12/5/1244

Preoperative Exclusive Total Parental Nutrition is ... In summary, exclusive preoperative TPN was associated with significant weight gain, decreased inflammatory biomarkers, improved nutritional status, and improved ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05127109

Study Details | NCT05127109 | The PASTDUe Nutrition ... The purpose of this prospective trial is to study the impact of the utilization of structured nutrition delivery pathway on 300 adult abdominal trauma and ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK559036/

Total Parenteral Nutrition - StatPearls - NCBI Bookshelf Total parenteral nutrition is a medication used to manage and treat malnourishment. It is in the nutrition class of drugs.

8. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1488054/full

Efficacy and safety of post-discharge oral nutritional ... Efficacy and safety of post-discharge oral nutritional supplements for patients with gastric cancer undergoing gastrectomy: a meta-analysis of randomized ...