Improving nutrition delivery for ICU patients after abdominal surgery
The PASTDUe Nutrition EcoSystem Pathway In Acute Care Abdominal Surgery and Trauma to Decrease Underfeeding and Complications
This study tests a new way to provide better nutrition for adult ICU patients recovering from abdominal surgery to see if it helps them heal faster and improves their overall health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | cart |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05127109 on ClinicalTrials.gov |
What this trial studies
This research focuses on enhancing the nutritional support for adult patients in the ICU who have undergone abdominal surgery and require total parenteral nutrition (TPN). The study implements a structured nutrition delivery pathway that includes tube feeding, oral nutrition supplements, and the use of an indirect calorimeter to assess calorie needs. Patients will be monitored throughout their hospitalization to evaluate changes in nutrition status, fat, and muscle mass. The outcomes will be compared to a historical control group to assess the effectiveness of this approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are admitted to the ICU with major abdominal trauma or related conditions and are not expected to receive oral or enteral nutrition for more than 72 hours.
Not a fit: Patients who are expected to die or have life-sustaining treatment withdrawn within the first 72 hours of ICU admission may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved clinical outcomes and reduced complications for ICU patients requiring nutritional support after abdominal surgery.
How similar studies have performed: Other studies have shown promising results with structured nutrition delivery approaches in similar patient populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \>= 18 years 2. ICU admission with major abdominal trauma, intra-abdominal sepsis, ischemic bowel/vascular emergencies, or penetrating trauma 3. Not expected to receive oral or enteral nutrition for \> 72 hours 4. Primary team approval of PN 4. \< 72 hours post-operative intervention Exclusion Criteria: 1. Expected death or withdrawal of life-sustaining treatment within the first 72 hours of ICU admission 2. Patients admitted with * Diabetic ketoacidosis or non-ketotic hyperosmolar coma * MELD \> 20 or acute fulminant hepatic failure 3. Patients allergic to any component of parenteral nutrition or lipid solution 4. Pregnant or breastfeeding patients 5. Incarcerated or prisoner prior to admission
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Paul Wischmeyer — Duke University
- Study coordinator: Paul E. Wischmeyer, MD
- Email: paul.wischmeyer@duke.edu
- Phone: 919-681-6437
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.