← Back to Search

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
Select...
I am 18 years old or older.
Select...
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:
Select...
I was hospitalized for severe diabetes complications.
Select...
My liver is severely damaged.

Timeline

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.

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.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,451 Previous Clinical Trials
2,971,459 Total Patients Enrolled
14 Trials studying Sepsis
53,376 Patients Enrolled for Sepsis
Paul WischmeyerPrincipal InvestigatorDuke University
2 Previous Clinical Trials
18 Total Patients Enrolled

Media Library

Nutrition Ecosystem pathway Clinical Trial Eligibility Overview. Trial Name: NCT05127109 — Phase 4
Sepsis Research Study Groups: Comparator, Nutrition Ecosystem pathway
Sepsis Clinical Trial 2023: Nutrition Ecosystem pathway Highlights & Side Effects. Trial Name: NCT05127109 — Phase 4
Nutrition Ecosystem pathway 2023 Treatment Timeline for Medical Study. Trial Name: NCT05127109 — Phase 4
~9 spots leftby Jan 2025