Critical Illness
Conditions
Keywords
time-restricted feeding, enteral feeding, critical illness, intermittent fasting
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.
Interventions
OTHER12-hour time-restricted feeding (TRF12)
The 12 hour feeding group will receive tube feeding only over a 12 hour period (6:00 AM to 6:00 PM feeding schedule).
OTHERContinuous 24 hour feeding (CONT24).
Patients in this control group will receive the standard of care which is tube feeding continuously over 24 hours.
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and feasibility | From randomization up to 10 days | Safety will be measured by the need for pausing or discontinuing enteral feeds, gastrointestinal complications (including vomiting, abdominal distention, and diarrhea), other feeding complications (e.g., aspiration, gastric residuals), and hypoglycemic events. Feasibility is defined as the percentage of patients who received ≥75% of their prescribed nutrition goal, and the logistical feasibility of collecting study data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control | From randomization up to 10 days | Glycemic control will be assessed using a continuous glucose monitor to measure time-in-range (%), time-above-range, and number of hypoglycemic events. |
| Sleep quantity | From randomization up to 10 days | Sleep quantity scores will be measured in hours using actigraphy and the Richards-Campbell Sleep questionnaire. |
| Circadian rhythm of skin surface temperature | From randomization up to 10 days | Circadian rhythm of skin surface temperature will be measured across 24-hours and the phase and amplitude of the circadian rhythm of skin temperature will be quantified |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFelicia Steger, PhD, MS, RD
University of Kansas Medical Center
Outcome results
None listed