Diet, HealthyPhase 4PASTDUeNCT05127109
The PASTDUe Nutrition Ecosystem Project (PASTDUe)
A Phase 4 study testing Nutrition Ecosystem pathway and Comparator in people with Diet, Healthy and Food, run by Duke University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diet, Healthy, Food, Nutrition
- What is being tested?
- Nutrition Ecosystem pathway and Comparator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2022to 20 Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years
- ICU admission with major abdominal trauma, intra-abdominal sepsis, ischemic bowel/vascular emergencies, or penetrating trauma
- Not expected to receive oral or enteral nutrition for > 72 hours
- Primary team approval of PN
- 4. < 72 hours post-operative intervention
Who cannot join
- Expected death or withdrawal of life-sustaining treatment within the first 72 hours of ICU admission
- Patients admitted with
- Diabetic ketoacidosis or non-ketotic hyperosmolar coma
- MELD > 20 or acute fulminant hepatic failure
- Patients allergic to any component of parenteral nutrition or lipid solution
- Pregnant or breastfeeding patients
- Incarcerated or prisoner prior to admission
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: The PASTDUe Nutrition EcoSystem Pathway In Acute Care Abdominal Surgery and Trauma to Decrease Underfeeding and Complications
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.
Read the detailed description
The purpose of this prospective trial is to study the impact of the utilization of structured nutrition delivery pathway on 300 adult abdominal trauma and surgery patients admitted to a Duke University Medical Center (DUMC) intensive care unit (ICU) through a structured nutrition delivery pathway from surgical intervention to hospital discharge. Objectives include evaluating the impact of a structured nutrition delivery pathway on 1) nosocomial infectious complications as defined by CDC guidelines after 7 days of ICU admission and 2) protein-calorie malnutrition, ventilator use, hospital disposition, hospital and ICU length of stay, ED/hospital utilization, total parenteral nutrition (TPN)-related complications, 1-year mortality, and hospital charges. Patient outcomes will be compared to a retrospective cohort of 300 historical matched control subjects.
The study intervention, a structured nutrition delivery pathway called the Nutrition Ecosystem pathway consists of the following collaborative parts to optimize nutrition intake and delivery within this patient population: 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. The population group will consist of 300 surgical patients admitted to a DUMC ICU following emergent/urgent major abdominal surgery secondary to abdominal trauma, intra-abdominal sepsis, ischemic bowel/vascular emergencies, or penetrating trauma and are not expected to receive enteral or oral nutrition for at least 72 hours. 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.
This study poses minimal risks to patients as the study activities match the current standard of care medical treatment such as nutrition delivery via TPN. Patients will benefit from metabolic and physiologic assessments, closer monitoring, and interdisciplinary support for nutrition optimization from nurses, dietitians, and providers throughout their hospitalization. Given patients' energy expenditure will be routinely measured by indirect calorimetry via a metabolic cart, a greater accuracy in caloric requirements will help achieve precision and goal nutrition for all participants.
- Conditions
- Diet, Healthy, Food, Nutrition, Intensive Care, Abdominal Trauma, Surgery
- Being tested
- Nutrition Ecosystem pathway, Comparator
- Medical subject headings
- Abdominal Injuries, Intraabdominal Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition Ecosystem pathwayCombination product
- parenteral nutrition initiated within 72 hours of operative intervention
- Provided as clinically appropriate: Ensure Enlive, Ensure High-Protein, Nepro with Carb-Steady/ProSource Gelatein Plus, and/or ProSource Gelatein Plus
- metabolic cart assessments to determine resting energy expenditure (REE) and guide registered dietitians (RDs)
- Q-NRG Metabolic Cart (Indirect Calorimeter) and Quark RMR Metabolic Cart (Indirect Calorimeter)
- BWA 2.0 Advanced Bioelectric Impedance Spectroscopy (BIS)
- Philips Lumify L12-4 broadband linear array transducer ultrasound
- expedited delivery of oral nutrition supplements and
- a team-based approach on proper documentation of nutrition delivery and intake
ComparatorOther
retrospective cohort of 300 historical matched control subjects
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Ecosystem pathway | Experimental | 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. Receives: Combination Product: Nutrition Ecosystem pathway |
| Comparator | Other | 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. Receives: Other: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of nosocomial infection complications as measured by medical record review
Measured: From TPN initiation, daily until hospital discharge (up to 8 months)
ICU length of stay in days measured by medical record review
Measured: From TPN initiation, daily until hospital discharge (up to 8 months)
Secondary outcomes (11)
Incidence of protein-calorie malnutrition measured using AND/ASPEN-defined malnutrition criteria
Measured: Measured daily from hospital admission to hospital discharge (up to 8 months)
Number of days patient is on ventilator measured by medical record review
Measured: Measured daily from hospital admission up to hospital discharge (up to 8 months)
Number of patients discharged home measured by medical record review/patient report
Measured: Recorded at hospital discharge (up to 8 months)]
Number of patients discharged to rehabilitation center measured by medical record review/patient report
Measured: Recorded at hospital discharge (up to 8 months)]
Number of patients discharged to nursing home measured by medical record review/patient report
Measured: Recorded at hospital discharge (up to 8 months)]
ICU length of stay in days measured by medical record review
Measured: Measured from ICU admission to ICU discharge (up to 8 months)
Length of hospital stay in days as measured by medical record review
Measured: Measured from hospital admission to hospital discharge (up to 8 months)
Incidence of ED/hospital utilization as measured by medical record review/patient report
Measured: Measured from hospital discharge to 1-year post-hospital discharge]
Number of TPN-related complications as measured by medical record review/patient report
Measured: Measured from TPN initiation until completion of TPN course/treatment (up to 8 months)
Number of the different types of TPN-related complications as measured by medical record review/patient report
Measured: Measured from TPN initiation until completion of TPN course/treatment(up to 8 months)
Number of deaths in 1-year as measured by medical record review/Legally Authorized Representative report
Measured: Measured from hospital discharge to 1-year post-hospital discharge]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start25 Apr 2022
- Primary completion20 Feb 2026
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Utilization of structured nutrition delivery pathway on 300 adult abdominal trauma and surgery patients admitted to a Duke University Medical Center (DUMC) intensive care unit (ICU) from surgical intervention to hospital discharge.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Wischmeyer, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127109
- Sponsor's protocol ID
- Pro00107553
- Acronym
- PASTDUe
- Status last verified
- Jan 2026
- First submitted
- 9 Nov 2021
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PASTDUe Nutrition EcoSystem Pathway In Acute Care Abdominal Surgery and Trauma to Decrease Underfeeding and Complications
- ClinicalTrials.gov ID
- NCT05127109
- Acronym / sponsor ID
- PASTDUe / Pro00107553
- Conditions
- Diet, Healthy, Food, Nutrition, Intensive Care, Abdominal Trauma, Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this prospective trial is to study the impact of the utilization of structured nutrition delivery pathway on 300 adult abdominal trauma and surgery patients admitted to a Duke University Medical Center (DUMC) intensive care unit (ICU) through a structured nutrition delivery pathway from surgical intervention to hospital discharge. Objectives include evaluating the impact of a structured nutrition delivery pathway on 1) nosocomial infectious complications as defined by CDC guidelines after 7 days of ICU admission and 2) protein-calorie malnutrition, ventilator use, hospital disposition, hospital and ICU length of stay, ED/hospital utilization, total parenteral nutrition (TPN)-related complications, 1-year mortality, and hospital charges. Patient outcomes will be compared to a retrospective cohort of 300 historical matched control subjects.
The study intervention, a structured nutrition delivery pathway called the Nutrition Ecosystem pathway consists of the following collaborative parts to optimize nutrition intake and delivery within this patient population: 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. The population group will consist of 300 surgical patients admitted to a DUMC ICU following emergent/urgent major abdominal surgery secondary to abdominal trauma, intra-abdominal sepsis, ischemic bowel/vascular emergencies, or penetrating trauma and are not expected to receive enteral or oral nutrition for at least 72 hours. 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.
This study poses minimal risks to patients as the study activities match the current standard of care medical treatment such as nutrition delivery via TPN. Patients will benefit from metabolic and physiologic assessments, closer monitoring, and interdisciplinary support for nutrition optimization from nurses, dietitians, and providers throughout their hospitalization. Given patients' energy expenditure will be routinely measured by indirect calorimetry via a metabolic cart, a greater accuracy in caloric requirements will help achieve precision and goal nutrition for all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Utilization of structured nutrition delivery pathway on 300 adult abdominal trauma and surgery patients admitted to a Duke University Medical Center (DUMC) intensive care unit (ICU) from surgical intervention to hospital discharge.
| Arm | Type | Receives |
|---|---|---|
| Nutrition Ecosystem pathway | Experimental | Combination Product: Nutrition Ecosystem pathway1. 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. |
| Comparator | Other | Other: Comparator300 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >= 18 years
- ICU admission with major abdominal trauma, intra-abdominal sepsis, ischemic bowel/vascular emergencies, or penetrating trauma
- Not expected to receive oral or enteral nutrition for > 72 hours
- Primary team approval of PN
- 4. < 72 hours post-operative intervention
Key exclusion criteria (7 listed)
- Expected death or withdrawal of life-sustaining treatment within the first 72 hours of ICU admission
- Patients admitted with
- Patients allergic to any component of parenteral nutrition or lipid solution
- Pregnant or breastfeeding patients
- Incarcerated or prisoner prior to admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition Ecosystem pathway1. parenteral nutrition initiated within 72 hours of operative intervention * Provided as clinically appropriate: Ensure Enlive, Ensure High-Protein, Nepro with Carb-Steady/ProSource Gelatein Plus, and/or ProSource Gelatein Plus 2. metabolic cart assessments to determine resting energy expenditure (REE) and guide registered dietitians (RDs) * Q-NRG Metabolic Cart (Indirect Calorimeter) and Quark RMR Metabolic Cart (Indirect Calorimeter) * BWA 2.0 Advanced Bioelectric Impedance Spectroscopy (BIS) * Philips Lumify L12-4 broadband linear array transducer ultrasound 3. expedited delivery of oral nutrition supplements and 4. a team-based approach on proper documentation of nutrition delivery and intake | Combination product | Nutrition Ecosystem pathway |
| Comparatorretrospective cohort of 300 historical matched control subjects | Other | Comparator |
Primary outcome
Number of nosocomial infection complications as measured by medical record review
Time frame: From TPN initiation, daily until hospital discharge (up to 8 months)
ICU length of stay in days measured by medical record review
Time frame: From TPN initiation, daily until hospital discharge (up to 8 months)
11 secondary outcomes
Incidence of protein-calorie malnutrition measured using AND/ASPEN-defined malnutrition criteria
Time frame: Measured daily from hospital admission to hospital discharge (up to 8 months)
Number of days patient is on ventilator measured by medical record review
Time frame: Measured daily from hospital admission up to hospital discharge (up to 8 months)
Number of patients discharged home measured by medical record review/patient report
Time frame: Recorded at hospital discharge (up to 8 months)]
Number of patients discharged to rehabilitation center measured by medical record review/patient report
Time frame: Recorded at hospital discharge (up to 8 months)]
Number of patients discharged to nursing home measured by medical record review/patient report
Time frame: Recorded at hospital discharge (up to 8 months)]
ICU length of stay in days measured by medical record review
Time frame: Measured from ICU admission to ICU discharge (up to 8 months)
Length of hospital stay in days as measured by medical record review
Time frame: Measured from hospital admission to hospital discharge (up to 8 months)
Incidence of ED/hospital utilization as measured by medical record review/patient report
Time frame: Measured from hospital discharge to 1-year post-hospital discharge]
Number of TPN-related complications as measured by medical record review/patient report
Time frame: Measured from TPN initiation until completion of TPN course/treatment (up to 8 months)
Number of the different types of TPN-related complications as measured by medical record review/patient report
Time frame: Measured from TPN initiation until completion of TPN course/treatment(up to 8 months)
Number of deaths in 1-year as measured by medical record review/Legally Authorized Representative report
Time frame: Measured from hospital discharge to 1-year post-hospital discharge]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Wischmeyer principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nutrition Ecosystem pathway and Comparator in people with Diet, Healthy and Food, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of nosocomial infection complications as measured by medical record review (time frame: From TPN initiation, daily until hospital discharge (up to 8 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.