Status:
RECRUITING
12-hour Time Limited Feeding in Critical Care
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 pr...
Detailed Description
Investigators will test a 12-hour time-restricted feeding (TRF12) protocol in critically ill adults and compare this to a standard-of-care, 24-hour continuous feeding (CONT24) schedule. Time-restricte...
Eligibility Criteria
Inclusion Criteria:
- Adults (≥18 years of age)
- With critical illness (hospitalized in an intensive care unit with a status of "ICU")
- Who have received orders for continuous enteral nutrition
Exclusion Criteria:
- "Comfort Measures Only" status
- Have orders to receive trickle feedings (feeding rate ≤10mL/hr)
- Recent surgical procedure on the GI tract (within previous 5 days at time of recruitment) or admission for GI bleed
- Receiving continuous sedation
- Expected to undergo a procedure requiring removal of study devices in the three days following enrollment
- History of malabsorptive bariatric surgery
- Admitted for a burn injury
- Known intolerance to feeding rates >100mL/hr
- Current diagnosis of pancreatitis, ileus or gastroparesis (only if using a gastrostomy tube)
- Requiring intermittent or continuous renal replacement therapy
- Pregnant or lactating
- On an intermittent feeding schedule
- Nutritional needs would require a rate higher than 120mL/hr on TRF12 protocol
- Lack of clearance by primary physician
Key Trial Info
Start Date :
March 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06741761
Start Date
March 25 2025
End Date
June 1 2026
Last Update
January 8 2026
Active Locations (1)
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1
University Of Kansas Health System
Kansas City, Kansas, United States, 66103