Clinical trial NCT06741761: 12-hour Time Limited Feeding in Critical Care
Official title: The Safety and Feasibility of a 12-hour Time-Limited Enteral Feeding Protocol in Critically Ill Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Keywords: time-restricted feeding
enteral feeding
critical illness
intermittent fasting
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.

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-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.

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

Primary outcomes:
measure: Safety and feasibility
timeFrame: From randomization up to 10 days
Secondary outcomes:
measure: Glycemic control
timeFrame: From randomization up to 10 days
measure: Sleep quantity
timeFrame: From randomization up to 10 days
measure: Circadian rhythm of skin surface temperature
timeFrame: From randomization up to 10 days
Other outcomes:
measure: Mental health
timeFrame: From 1 month and 3 months post-discharge
measure: Cognitive health
timeFrame: From 1 month and 3 months post-discharge
measure: Impact of Health Status on Quality of life
timeFrame: From 1 month and 3 months post-discharge
Locations:
city: Kansas City
country: United States
facility: University Of Kansas Health System
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Felicia Steger, PhD, MS, RD
role: PRINCIPAL_INVESTIGATOR
References: