12-hour Time Limited Feeding in Critical Care

Running, not enrolling · Not applicable

Conditions studied: Critical Illness

In brief

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.

Key facts

Study ID

NCT06741761

Run by

University of Kansas Medical Center

People needed

20

Starts

2025-03-25

Expected to finish

2026-06-01

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• "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

Where it is running

• University Of Kansas Health System — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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