An interventional study of standard enteral nutrition and restricted enteral nutrition in Critical Illness, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-12-29.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Prevention
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.
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.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's planned enrollment of 300 is above the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
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Exclusion Criteria:
Enteral nutrition was fed at 10-20kcal/kg/d for the first three days before identifying the refeeding syndrome
Dietary Supplement: restricted enteral nutrition
Enteral nutrition was fed at 500-750kcal/d for the first three days before identifying the refeeding syndrome
Dietary Supplement: standard enteral nutrition
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.
It is not up to the RFS definition
Enteral nutrition was treated within 48 hours after ICU and the calories were 500-750kcal/d
Enteral nutrition was treated within 48 hours after ICU and the calories were 10-20kcal/kg/d for 3 days
The best diagnostic criteria for refeeding syndrome
Evaluate the best timing for intervention according to the lowest and the decline of serum phosphate
Time frame: 1 month mortality and the duration of mechanical ventilation
the incidence of refeeding syndrome
only according to serum phosphate standard
Time frame: 3 day after treated with nutrition
duration of mechanical ventilation
The duration of mechanical ventilation in General ICU of our department in the same time admitted to ICU
Time frame: 30 days
survival rate
including discharge from hospital and ICU
Time frame: 28 days
occurrence of complications
including feeding intolerance, electrolyte disturbance
Time frame: 7 days
Plan to share: Yes — One year after the article was published, and the opening lasted for one year
Supporting information: Study protocol, Sap, Csr
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Refeeding Syndrome
Second Affiliated Hospital, School of Medicine, Zhejiang University