The PASTDUe Nutrition Ecosystem Project (PASTDUe)

NCT05127109 | Active Not Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: Pro00107553
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Diet, Healthy; Food; Nutrition; Intensive Care; Surgery; Intra-abdominal Infection; Sepsis; Ischemic Bowel; Vascular; Penetrating Abdominal Trauma; Enteral Feeding; Oral; Abdominal Trauma

Outcome Measures

Primary Outcomes (2)

• Number of nosocomial infection complications as measured by medical record review

  From TPN initiation, daily until hospital discharge (up to 8 months)

• ICU length of stay in days measured by medical record review

  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 daily from hospital admission to hospital discharge (up to 8 months)

• Number of days patient is on ventilator measured by medical record review

  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

  Recorded at hospital discharge (up to 8 months)]

• Number of patients discharged to rehabilitation center measured by medical record review/patient report

  Recorded at hospital discharge (up to 8 months)]

• Number of patients discharged to nursing home measured by medical record review/patient report

  Recorded at hospital discharge (up to 8 months)]

Study Arms (2)

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.

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.

Other: Comparator

Interventions

Comparator OTHER

retrospective cohort of 300 historical matched control subjects

Comparator

Nutrition Ecosystem pathway COMBINATION_PRODUCT

1. 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

Nutrition Ecosystem pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \. \< 72 hours post-operative intervention

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Abdominal Injuries; Intraabdominal Infections; Sepsis

Condition Hierarchy (Ancestors)

Wounds and Injuries; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Wischmeyer

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 19, 2021
• Study Start: April 25, 2022
• Primary Completion: February 20, 2026
• Study Completion (Estimated): February 20, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)