12-hour Time Limited Feeding in Critical Care

University of Kansas

Status: Enrolling

Conditions: Critical Illness

Treatments: Other: Continuous 24 hour feeding (CONT24).; Other: 12-hour time-restricted feeding (TRF12)

Study type: Interventional

Funder types: Other

Identifiers

NCT06741761

00161009

Details and patient eligibility

About

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.

Full 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-restricted feeding (TRF) is form of intermittent fasting involving eating within a consistent, shortened period each day, following by fasting for at least 12 hours daily. TRF may improve glycemic control, blood pressure, and circadian rhythms in metabolism relative to feeding over a longer period. In critically ill patients, most facilities feed enterally over 24-hours which may exacerbate sleep disturbances and post-intensive care syndrome. In addition to safety and feasibility measures, this 10-day trial will gather preliminary data regarding how these feeding protocols each affect glycemic control, sleep, and long-term effects of critical care, such as delirium.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Continuous 24 hour feeding (CONT24).

Active Comparator group

Description:

24 hour tube feeding is the standard of care. They will receive tube feeding continuously over 24 hours daily.

Treatment:

Other: Continuous 24 hour feeding (CONT24).

12-hour time-restricted feeding (TRF12)

Experimental group

Description:

The 12-hour time-restricted feeding group will receive the same amount of nutrition in 12 hours as would be needed in 24 hours. The hourly feeding rate will double.

Treatment:

Other: 12-hour time-restricted feeding (TRF12)