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