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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured from hospital discharge to 1-year post-hospital discharge]
Awards & highlights

PASTDUe Trial Summary

This trial will test whether a new method of providing nutrition to patients who have had abdominal surgery and require nutrition through their veins improves clinical outcomes.

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.Check my eligibility
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.See study design
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.

PASTDUe Trial 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.

PASTDUe Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured from hospital discharge to 1-year post-hospital discharge]
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured from hospital discharge to 1-year post-hospital discharge] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of nosocomial infection complications as measured by medical record review
Secondary outcome measures
ICU length of stay in days measured by medical record review
Incidence of ED/hospital utilization as measured by medical record review/patient report
Incidence of protein-calorie malnutrition measured using AND/ASPEN-defined malnutrition criteria
+8 more

PASTDUe Trial Design

2Treatment groups
Experimental Treatment
Group I: Nutrition Ecosystem pathwayExperimental Treatment1 Intervention
parenteral nutrition initiated within 72 hours of operative intervention metabolic cart assessments to determine resting energy expenditure (REE) and guide registered dietitians (RDs) expedited delivery of oral nutrition supplements and 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.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,356 Previous Clinical Trials
3,408,801 Total Patients Enrolled
1 Trials studying Abdominal Trauma
150 Patients Enrolled for Abdominal Trauma
Paul WischmeyerPrincipal InvestigatorDuke University
2 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

Nutrition Ecosystem pathway Clinical Trial Eligibility Overview. Trial Name: NCT05127109 — Phase 4
Abdominal Trauma Research Study Groups: Nutrition Ecosystem pathway, Comparator
Abdominal Trauma 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What sort of hazards could be encountered when following the Nutrition Ecosystem pathway?

"There exists a significant amount of evidence supporting the safety profile of Nutrition Ecosystem pathway, resulting in it being assigned a score of 3."

Answered by AI

Are individuals currently eligible to join this medical trial?

"Affirmative, there is evidence on clinicaltrials.gov that this medical study has been open for recruitment since April 25th 2022 and was last updated on May 4th of the same year. The trial necessitates 300 participants from a single centre to partake in it."

Answered by AI

To what extent has this clinical trial attracted participants?

"Affirmative. According to clinicaltrials.gov, the trial is presently recruiting and opened on April 25th 2022 with its most recent update occurring May 4th of this year. 300 patients are needed at a single medical centre for the study's completion."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
Duke University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
~84 spots leftby Jan 2025