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

Status: Recruiting
Location: See location...
Intervention Type: Other, Combination product
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
North Carolina
Duke University Medical Center
RECRUITING
Durham
Contact Information
Primary
Paul E. Wischmeyer, MD
paul.wischmeyer@duke.edu
919-681-6437
Backup
Jeroen Molinger
jeroen.molinger@duke.edu
919-681-6437
Time Frame
Start Date: 2022-04-25
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 300
Treatments
Experimental: Nutrition Ecosystem pathway
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.
Other: Comparator
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.
Related Therapeutic Areas
Sponsors
Leads: Duke University

This content was sourced from clinicaltrials.gov