Condition or disease | Intervention/treatment | Phase |
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Critical Illness | Dietary Supplement: standard enteral nutrition Dietary Supplement: restricted enteral nutrition | Not Applicable |
Stage 1: the monitoring rate of re-feeding syndrome in our department was reviewed to evaluate the incidence of re-feeding syndrome in severe patients,which is not described in detail; Stage 2:This part is a prospective observational study,divided into two group,that is, RFS group(their serum phosphate concentration decreased to below 0.87 mmol/L within 72 h after starting nutritional support and the biological variation needed to be greater than 30% decrease from any concentration previously recorded), which is divided into three sub-group(Group 1 that a drop of >0.16 mmol/L from any previous measurement, to below 0.65 mmol/L within 72 h after starting nutritional support, Group 2 that their serum phosphate concentration decreased to below 0.87 mmol/L within 72 h after starting nutritional support and the biological variation needed to be greater than 30% decrease from any concentration previously recorded, and Group 3 that their serum phosphate concentration decreased to below 0•32 mmol/L within 72 h after starting nutritional support.), and nRFS group(non-RFS that the serum phosphate do not up to the criteria). And the RFS group will be receiving the low-calorie feeding intervention, the nRFS group will be receiving the standard feeding according to the ASPEN guideline of 2016.
Stage 3: On this basis of stage 2, it is assessed whether early low-calorie feeding could improve prognosis in high-risk patients with RFS who was defined in NICE(National institute for the health and care excellence).The part of stage 3, divided into two groups that standard calorie feeding group and low calorie feeding group, aims to assess whether early low-calorie feeding could improve prognosis in high-risk patients with RFS.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Prevention |
Official Title: | Application of Prophylactic Low Calorie Feeding in Critically Ill Patients With High-risk Refeeding Syndrome |
Actual Study Start Date : | July 1, 2019 |
Actual Primary Completion Date : | August 1, 2020 |
Estimated Study Completion Date : | August 1, 2021 |
Arm | Intervention/treatment |
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Experimental: low calorie feeding group
Enteral nutrition was fed at 10-20kcal/kg/d for the first three days before identifying the refeeding syndrome
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Dietary Supplement: restricted enteral nutrition
Enteral nutrition was treated within 48 hours after ICU and the calories were 10-20kcal/kg/d for 3 days
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Active Comparator: standard calorie feeding group
Enteral nutrition was fed at 500-750kcal/d for the first three days before identifying the refeeding syndrome
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Dietary Supplement: standard enteral nutrition
Enteral nutrition was treated within 48 hours after ICU and the calories were 500-750kcal/d
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No Intervention: RFS group
The definition of RFS is that serum phosphate concentration decreased to below 0.87 mmol/L within 72 h after starting nutritional support and the biological variation needed to be greater than 30% decrease from any concentration previously recorded. And it is divided into three sub-group that is Group 1 that a drop of >0.16 mmol/L from any previous measurement, to below 0.65 mmol/L within 72 h after starting nutritional support, Group 2 that their serum phosphate concentration decreased to below 0.87 mmol/L within 72 h after starting nutritional support and the biological variation needed to be greater than 30% decrease from any concentration previously recorded, and Group 3 that their serum phosphate concentration decreased to below 0•32 mmol/L within 72 h after starting nutritional support.
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No Intervention: nRFS group
It is not up to the RFS definition
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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: kongmiao lu, master | 18268061252 | lukongmiao123@163.com | |
Contact: man huang, phD |
China, Zhejiang | |
Second affiliated hospital, Zhejiang university school of medicine | Recruiting |
Hangzhou, Zhejiang, China, 310052 | |
Contact: lu kongmiao, master 018268061252 lukongmiao123@163.com | |
Contact: lu kongmiao |
Principal Investigator: | man huang, phD | Second affiliated hospital, Zhejiang university school of medicine | |
Study Director: | yunlong wu, master | Second affiliated hospital, Zhejiang university school of medicine |
Tracking Information | |||||||||||||||||
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First Submitted Date ICMJE | July 1, 2019 | ||||||||||||||||
First Posted Date ICMJE | July 2, 2019 | ||||||||||||||||
Last Update Posted Date | December 29, 2020 | ||||||||||||||||
Actual Study Start Date ICMJE | July 1, 2019 | ||||||||||||||||
Actual Primary Completion Date | August 1, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Change History | |||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | Application of Prophylactic Low Calorie Feeding in Critically Ill Patients With High-risk Refeeding Syndrome | ||||||||||||||||
Official Title ICMJE | Application of Prophylactic Low Calorie Feeding in Critically Ill Patients With High-risk Refeeding Syndrome | ||||||||||||||||
Brief 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. | ||||||||||||||||
Detailed Description |
Stage 1: the monitoring rate of re-feeding syndrome in our department was reviewed to evaluate the incidence of re-feeding syndrome in severe patients,which is not described in detail; Stage 2:This part is a prospective observational study,divided into two group,that is, RFS group(their serum phosphate concentration decreased to below 0.87 mmol/L within 72 h after starting nutritional support and the biological variation needed to be greater than 30% decrease from any concentration previously recorded), which is divided into three sub-group(Group 1 that a drop of >0.16 mmol/L from any previous measurement, to below 0.65 mmol/L within 72 h after starting nutritional support, Group 2 that their serum phosphate concentration decreased to below 0.87 mmol/L within 72 h after starting nutritional support and the biological variation needed to be greater than 30% decrease from any concentration previously recorded, and Group 3 that their serum phosphate concentration decreased to below 0•32 mmol/L within 72 h after starting nutritional support.), and nRFS group(non-RFS that the serum phosphate do not up to the criteria). And the RFS group will be receiving the low-calorie feeding intervention, the nRFS group will be receiving the standard feeding according to the ASPEN guideline of 2016. Stage 3: On this basis of stage 2, it is assessed whether early low-calorie feeding could improve prognosis in high-risk patients with RFS who was defined in NICE(National institute for the health and care excellence).The part of stage 3, divided into two groups that standard calorie feeding group and low calorie feeding group, aims to assess whether early low-calorie feeding could improve prognosis in high-risk patients with RFS. |
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Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Care Provider) Primary Purpose: Prevention |
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Condition ICMJE | Critical Illness | ||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||||
Estimated Enrollment ICMJE |
300 | ||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||
Estimated Study Completion Date ICMJE | August 1, 2021 | ||||||||||||||||
Actual Primary Completion Date | August 1, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 90 Years (Adult, Older Adult) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||||||||||||
Removed Location Countries | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT04005300 | ||||||||||||||||
Other Study ID Numbers ICMJE | refeeding syndrome | ||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||||||||||||||
Study Sponsor ICMJE | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||
Investigators ICMJE |
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PRS Account | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||||||||||||||
Verification Date | December 2020 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |