What side effects are associated with this type of intervention?

Common treatments for abdominal trauma, such as total parenteral nutrition (TPN) and enteral nutrition, can have several side effects. TPN is associated with risks like catheter-related infections, liver dysfunction, and metabolic imbalances. Enteral nutrition, while generally safer, can cause gastrointestinal complications such as diarrhea, constipation, and aspiration pneumonia. The use of indirect calorimetry to measure calorie needs and monitoring body composition changes are non-invasive and generally safe, but they require careful implementation to ensure accurate results and avoid potential discomfort for the patient.

What prior FDA approvals exist?

There are no specific FDA-approved drugs solely for the treatment of abdominal trauma that align directly with the Structured Nutrition Delivery Plan. However, total parenteral nutrition (TPN) is an FDA-approved method used to provide nutrition intravenously to patients who cannot consume food orally or enterally, which is relevant for patients with severe abdominal trauma. Indirect calorimetry, a non-invasive method to measure calorie needs, is also utilized in clinical settings to optimize nutritional support, although it is not a drug but a diagnostic tool. These methods are part of broader nutritional support strategies rather than specific FDA-approved treatments for abdominal trauma.

What other types of research exist?

Promising novel alternatives to the Structured Nutrition Delivery Plan for abdominal trauma patients include: 1) Early enteral nutrition, which has shown benefits in reducing postoperative complications and improving recovery times. 2) Immunonutrition, which involves supplementation with specific nutrients like arginine, omega-3 fatty acids, and nucleotides to enhance immune function and reduce infection rates. 3) Enhanced Recovery After Surgery (ERAS) protocols, which integrate multimodal perioperative care pathways, including optimized nutritional support, to improve patient outcomes. These alternatives focus on early and targeted nutritional interventions to support recovery and improve clinical outcomes.

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Nutrition Ecosystem for Post-Abdominal Surgery (PASTDUe Trial)

Phase 4

Recruiting

Led By Paul Wischmeyer

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18 years

ICU admission with major abdominal trauma, intra-abdominal sepsis, ischemic bowel/vascular emergencies, or penetrating trauma

Must not have

Patients admitted with diabetic ketoacidosis or non-ketotic hyperosmolar coma

Patients with MELD > 20 or acute fulminant hepatic failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this study involves nutritional support methods that are non-invasive and FDA-approved, risks are minimal. However, there may be potential discomfort from the use of an indirect calorimeter or bioelectrical impedance analysis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I was admitted to the ICU for severe abdominal issues or injuries.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was hospitalized for severe diabetes complications.

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My liver is severely damaged.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for abdominal trauma, particularly those involving structured nutrition delivery plans, focus on early enteral feeding, precise caloric measurement using indirect calorimetry, and monitoring body composition changes. Early enteral feeding supports gut integrity and immune function, while indirect calorimetry ensures patients receive the exact caloric intake needed for recovery. Monitoring body composition helps tailor nutritional interventions to maintain muscle mass and support healing, which is crucial for improving clinical outcomes and reducing hospital stay duration.

Impact of enteral nutrition on nitrogen balance in patients of trauma.