12-hour Time Limited Feeding in Critical Care (NCT06741761) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
12-hour Time Limited Feeding in Critical Care
United States20 participantsStarted 2025-03-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.