RECRUITING

12-hour Time Limited Feeding in Critical Care

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 study is being done to assess the feasibility and safety of a time-restricted 12-hour enteral feeding protocol (experimental group) in comparison to a standard-of-care, 24-hour enteral feeding protocol (control group) in critically ill patients. Investigators hope to gain knowledge about how these feeding schedules affect feeding tolerance, blood sugar control, and other factors affecting critically ill adult patients. * Investigators expect that the 12-hour feeding protocol will be tolerated similarly to the 24-hour feeding protocol and will not result in a greater number of adverse events related to feeding. * Investigators expect that the proportion of participants in both groups receiving at least 75% of their estimated nutrition needs will be similar.

Official Title

The Safety and Feasibility of a 12-hour Time-Limited Enteral Feeding Protocol in Critically Ill Adults

Quick Facts

Study Start:2025-03-25
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06741761

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. * Adults (≥18 years of age)
  2. * With critical illness (hospitalized in an intensive care unit with a status of "ICU")
  3. * Who have received orders for continuous enteral nutrition
  1. * "Comfort Measures Only" status
  2. * Have orders to receive trickle feedings (feeding rate ≤10mL/hr)
  3. * Recent surgical procedure on the GI tract (within previous 5 days at time of recruitment) or admission for GI bleed
  4. * Receiving continuous sedation
  5. * Expected to undergo a procedure requiring removal of study devices in the three days following enrollment
  6. * History of malabsorptive bariatric surgery
  7. * Admitted for a burn injury
  8. * Known intolerance to feeding rates \>100mL/hr
  9. * Current diagnosis of pancreatitis, ileus or gastroparesis (only if using a gastrostomy tube)
  10. * Requiring intermittent or continuous renal replacement therapy
  11. * Pregnant or lactating
  12. * On an intermittent feeding schedule
  13. * Nutritional needs would require a rate higher than 120mL/hr on TRF12 protocol
  14. * Lack of clearance by primary physician

Contacts and Locations

Study Contact

Felicia Steger, PhD, MS, RD
CONTACT
913-945-5822
fsteger@kumc.edu
Annie Henderson, RD
CONTACT
913-735-5411
aeller2@kumc.edu

Principal Investigator

Felicia Steger, PhD, MS, RD
PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center

Study Locations (Sites)

University Of Kansas Health System
Kansas City, Kansas, 66103
United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

  • Felicia Steger, PhD, MS, RD, PRINCIPAL_INVESTIGATOR, University of Kansas Medical Center

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 Date2025-03-25
Study Completion Date2025-12

Study Record Updates

Study Start Date2025-03-25
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • time-restricted feeding
  • enteral feeding
  • critical illness
  • intermittent fasting

Additional Relevant MeSH Terms

  • Critical Illness