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The PASTDUe Nutrition Ecosystem Project (PASTDUe)

Study acronym: PASTDUe
StatusActive, Not Recruiting
PhasePhase 4
Started2022-04-25
View on ClinicalTrials.gov ↗

Amendment history

2026-04-22
minor
Study Status v7
Primary completion dateestimated 2026-02-15→confirmed 2026-02-20
Completion date2027-02-15→2027-02-20
2026-01-28
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v6
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-12-01→2026-02-15
Completion date2026-01-01→2027-02-15
Study sitesdetails revised at 1 of 1 site
2025-02-03
minor
Study Status v5
Primary completion date2025-01-01→2025-12-01
2024-04-16
minor
2 amendments v3-v4
2 re-verifications since 2023-04-17, no change to tracked fields
2022-05-04
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-04-01→confirmed 2022-04-25
Study sitesdetails revised at 1 of 1 site
2022-01-14
minor
Study Status v1
Start date2021-12-01→2022-04-01
2021-11-09
minor
Original filing
455 trials monitored
See 53 trials at risk
This is a research study to determine if a particular method of providing nutrition improves the clinical outcomes of patients in the intensive care unit (ICU) who have undergone abdominal surgery and would require nutrition delivered via the bloodstream (called total parenteral nutrition or TPN). The nutrition method we are testing is a structured nutrition delivery plan that involves tube feeding, oral nutrition supplements, and the use of a device (called an indirect calorimeter or IC) to measure calorie needs. This study will also use two devices to measure fat and muscle mass to examine changes during hospitalization. Subjects will be followed throughout hospitalization where nutrition status and fat and muscle mass will be closely monitored. Study activities will begin within 72 hours of a patient's abdominal surgery. TPN (total parenteral nutrition, a method of feeding that bypasses the usual process of eating and digestion) will be started, a non-invasive method of assessing calorie needs (indirect calorimetry (IC)) will be started, a urine sample will be collected to help assist in protein needs, and fat/muscle mass will be measured using bioelectrical impedance analysis (BIA), and an ultrasound. This is a minimal risk study and all products/devices used are non-invasive and FDA-approved. Indirect calorimetry and urine sample collection will be conducted every 3 days during the stay in the Intensive Care Unit - ICU, then every 5 days until hospital discharge. BIA and muscle ultrasound will be conducted every 7 days during ICU stay, then every 14 days until hospital discharge.
Trial Details
NCT Number NCT05127109
Lead Sponsor Duke University
Conditions Diet, Healthy, Food, Nutrition, Intensive Care, Abdominal Trauma, Surgery, Intra-abdominal Infection, Sepsis +5 more
Enrollment 300 participants
Start Date 2022-04-25
Primary Completion 2026-02-20 (estimated)
Study Completion 2027-02-20 (estimated)
Updated on ClinicalTrials.gov 2026-04-23