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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous 24 hour feeding (CONT24). | Active Comparator | 24 hour tube feeding is the standard of care. They will receive tube feeding continuously over 24 hours daily. |
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| 12-hour time-restricted feeding (TRF12) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12-hour time-restricted feeding (TRF12) | Other | The 12 hour feeding group will receive tube feeding only over a 12 hour period (6:00 AM to 6:00 PM feeding schedule). |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and feasibility | 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. | From randomization up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic control | Glycemic control will be assessed using a continuous glucose monitor to measure time-in-range (%), time-above-range, and number of hypoglycemic events. | From randomization up to 10 days |
| Sleep quantity |
| Measure | Description | Time Frame |
|---|---|---|
| Mental health | Mental health will be measured using the Personal Health Questionnaire-9 (PHQ-9). To provide a numerical score, we will assess anxiety, depression, and post-traumatic stress syndrome. The total score ranges from 0 to 27, with higher scores indicating more severe anxiety, depression and post-traumatic stress syndrome. | From 1 month and 3 months post-discharge |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felicia Steger, PhD, MS, RD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Kansas Health System | Kansas City | Kansas | 66103 | United States |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005215 | Fasting |
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| Continuous 24 hour feeding (CONT24). | Other | Patients in this control group will receive the standard of care which is tube feeding continuously over 24 hours. |
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Sleep quantity scores will be measured in hours using actigraphy and the Richards-Campbell Sleep questionnaire.
| From randomization up to 10 days |
| Circadian rhythm of skin surface temperature | 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 | From randomization up to 10 days |
| Cognitive health | National Institutes of Health Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) will be used to assess depression or anxiety as a T-score two standard deviations above the mean. A higher score in each category indicates more of the concept being measured. | From 1 month and 3 months post-discharge |
| Impact of Health Status on Quality of life | Investigators will use the Health-Related Quality of Life survey to provide a measure of the impact of health status on quality of life. | From 1 month and 3 months post-discharge |
| D005247 | Feeding Behavior |
| D001519 | Behavior |