Nutrition Ecosystem for Post-Abdominal Surgery

(PASTDUe Trial)

Overseen by Paul Wischmeyer

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. ^{1 2 3 4 5}

Is 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. ^{3 6 7 8 9}

How 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. ^{4 6 8 10 11}

Research Team

Paul Wischmeyer

Principal Investigator

Duke University

Eligibility 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.

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

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

Treatment Details

Interventions

• Nutrition Ecosystem pathway (Behavioural Intervention)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The value of peri-operative nutrition in the sick patient. [2019]

2. France pubmed.ncbi.nlm.nih.gov

[Respective indications of enteral or parenteral nutrition during pre- and post-operative periods]. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Total parenteral nutrition: potion or poison? [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Quick recovery of serum diamine oxidase activity in patients undergoing total gastrectomy by oral enteral nutrition. [2012]

5. United States pubmed.ncbi.nlm.nih.gov

Perioperative nutritional support. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Short-chain fatty acid-supplemented total parenteral nutrition improves nonspecific immunity after intestinal resection in rats. [2017]

7. Switzerland pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Selective growth of mucolytic bacteria including Clostridium perfringens in a neonatal piglet model of total parenteral nutrition. [2022]

9. United States 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. [2017]

10. Germany pubmed.ncbi.nlm.nih.gov

Clinical-pharmacological aspects, application and effectiveness of total parenteral nutrition in surgical patients. [2013]

11. England 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]. [2013]