Application of Prophylactic Low Calorie Feeding in Critically Ill Patients With High-risk Refeedi… (NCT04005300) | Clinical Trial Compass
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Application of Prophylactic Low Calorie Feeding in Critically Ill Patients With High-risk Refeeding Syndrome
China300 participantsStarted 2019-07-01
Plain-language summary
Critically ill patients with high-risk nutrition are often at risk of refeeding syndrome(RFS), that the incidence of RFS is as high as 30-50%. It is sure that patients with refeeding syndrome were treated with restrictive enteral nutrition, but the definition of refeeding syndrome is not uniform, and there is still a lack of awareness high-risk patients of RFS to receiving early empirical low-calorie feeding intervention. So, we designed the study which is divided into three stages. Firstly, the monitoring rate of RFS was reviewed to evaluate the incidence of RFS in general ICU. Secondly, the best diagnostic criteria of RFS were prospectively defined. Finally, on this basis, it is assessed whether early low-calorie feeding could improve prognosis in high-risk patients with RFS.
Who can participate
Age range
18 Years – 90 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:
* Critically ill patients at least 18 years old;
* No history of enteral nutrition or parenteral nutrition within 1 week before ICU admission or ICU admission within 1 week;
* Mechanical ventilation patients requiring enteral nutrition support for \>72h
Exclusion Criteria:
* refuse to join this study;
* enteral nutrition support for less than 3 days or have enteral nutrition contraindication;
* less than 18 years old;
* artificial nutrition (enteral/parenteral nutrition) has been applied to patients before admission;
* other factors of hypophosphatemia: continuous hemodialysis, recent parathyroidectomy, or hyperphosphatemia after treatment;
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.
What they're measuring
1
The best diagnostic criteria for refeeding syndrome
Timeframe: 1 month mortality and the duration of mechanical ventilation
2
the incidence of refeeding syndrome
Timeframe: 3 day after treated with nutrition
Trial details
NCT IDNCT04005300
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University