RECRUITING

The PASTDUe Nutrition Ecosystem Project (PASTDUe)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The PASTDUe Nutrition EcoSystem Pathway In Acute Care Abdominal Surgery and Trauma to Decrease Underfeeding and Complications

Quick Facts

Study Start:2022-04-25
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05127109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age \>= 18 years
  2. 2. ICU admission with major abdominal trauma, intra-abdominal sepsis, ischemic bowel/vascular emergencies, or penetrating trauma
  3. 3. Not expected to receive oral or enteral nutrition for \> 72 hours
  4. 4. Primary team approval of PN
  5. 4. \< 72 hours post-operative intervention
  1. 1. Expected death or withdrawal of life-sustaining treatment within the first 72 hours of ICU admission
  2. 2. Patients admitted with
  3. * Diabetic ketoacidosis or non-ketotic hyperosmolar coma
  4. * MELD \> 20 or acute fulminant hepatic failure
  5. 3. Patients allergic to any component of parenteral nutrition or lipid solution
  6. 4. Pregnant or breastfeeding patients
  7. 5. Incarcerated or prisoner prior to admission

Contacts and Locations

Study Contact

Paul E. Wischmeyer, MD
CONTACT
919-681-6437
paul.wischmeyer@duke.edu
Jeroen Molinger
CONTACT
919-681-6437
jeroen.molinger@duke.edu

Principal Investigator

Paul Wischmeyer
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

Duke University Medical Center
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Duke University

  • Paul Wischmeyer, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-25
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2022-04-25
Study Completion Date2026-01-01

Terms related to this study

Additional Relevant MeSH Terms

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