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NCT05127109 · ClinicalTrials.gov registry record · Phase 4
The PASTDUe Nutrition Ecosystem Project (PASTDUe)
A Phase 4 study of Surgery and Sepsis, sponsored by Duke University.
- Active
- Registry status
- Phase 4
- Development phase
- 300
- Enrollment target
- 1
- Study location
NCT05127109 is a Phase 4 study of Surgery and Sepsis that is active but no longer recruiting, run by Duke University. The registered enrollment target is 300 participants, below the 52,849-participant average among 120 other Surgery trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05127109, a Phase 4 study of Surgery and Sepsis, is active but no longer recruiting, sponsored by Duke University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 300 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- OTHER Comparator
- COMBINATION_PRODUCT Nutrition Ecosystem pathway
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2022-04-25 |
| Est. Completion | 2027-02-15 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05127109
The ClinicalTrials.gov registry entry for NCT05127109 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 52,849-participant average among 120 other Surgery trials with a reported enrollment target (99% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Surgery appearing as the primary indexed condition, and to 2 interventions - of which Comparator is the first listed.
NCT05127109 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT05127109 about?
NCT05127109 is a clinical study titled "The PASTDUe Nutrition Ecosystem Project (PASTDUe)". 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). T...
What is the current status of trial NCT05127109?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 300 participants. The study started on 2022-04-25. Estimated completion is 2027-02-15.
What conditions does trial NCT05127109 study?
This clinical trial studies the following conditions: Surgery, Sepsis, Diet, Healthy, Nutrition, Abdominal Trauma.
What interventions are being tested in trial NCT05127109?
The interventions under investigation include: Comparator (OTHER), Nutrition Ecosystem pathway (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05127109?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05127109 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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