Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-03-25
2026-06-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Continuous 24 hour feeding (CONT24).
24 hour tube feeding is the standard of care. They will receive tube feeding continuously over 24 hours daily.
Continuous 24 hour feeding (CONT24).
Patients in this control group will receive the standard of care which is tube feeding continuously over 24 hours.
12-hour time-restricted feeding (TRF12)
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.
12-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).
Interventions
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12-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).
Continuous 24 hour feeding (CONT24).
Patients in this control group will receive the standard of care which is tube feeding continuously over 24 hours.
Eligibility Criteria
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Inclusion Criteria
* With critical illness (hospitalized in an intensive care unit with a status of "ICU")
* Who have received orders for continuous enteral nutrition
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Kansas Medical Center
OTHER
Responsible Party
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Felicia Steger
Principal Investigator
Principal Investigators
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Felicia Steger, PhD, MS, RD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University Of Kansas Health System
Kansas City, Kansas, United States
Countries
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Central Contacts
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Facility Contacts
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Felicia Steger, PhD
Role: primary
Other Identifiers
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00161009
Identifier Type: -
Identifier Source: org_study_id
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