Critical Illness Clinical Trial
Official title:
Application of Prophylactic Low Calorie Feeding in Critically Ill Patients With High-risk Refeeding Syndrome
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | August 1, 2021 |
Est. primary completion date | August 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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; |
Country | Name | City | State |
---|---|---|---|
China | Second affiliated hospital, Zhejiang university school of medicine | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
China,
Doig GS, Simpson F, Heighes PT, Bellomo R, Chesher D, Caterson ID, Reade MC, Harrigan PW; Refeeding Syndrome Trial Investigators Group. Restricted versus continued standard caloric intake during the management of refeeding syndrome in critically ill adults: a randomised, parallel-group, multicentre, single-blind controlled trial. Lancet Respir Med. 2015 Dec;3(12):943-52. doi: 10.1016/S2213-2600(15)00418-X. Epub 2015 Nov 18. — View Citation
Rio A, Whelan K, Goff L, Reidlinger DP, Smeeton N. Occurrence of refeeding syndrome in adults started on artificial nutrition support: prospective cohort study. BMJ Open. 2013 Jan 11;3(1). pii: e002173. doi: 10.1136/bmjopen-2012-002173. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The best diagnostic criteria for refeeding syndrome | Evaluate the best timing for intervention according to the lowest and the decline of serum phosphate | 1 month mortality and the duration of mechanical ventilation | |
Primary | the incidence of refeeding syndrome | only according to serum phosphate standard | 3 day after treated with nutrition | |
Secondary | duration of mechanical ventilation | The duration of mechanical ventilation in General ICU of our department in the same time admitted to ICU | 30 days | |
Secondary | survival rate | including discharge from hospital and ICU | 28 days | |
Secondary | occurrence of complications | including feeding intolerance, electrolyte disturbance | 7 days |
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