Application of Prophylactic Low Calorie Feeding in Critically Ill Patients With High-risk Refeeding Syndrome

Not Applicable

• Conditions: Critical Illness
• Interventions: Dietary Supplement: standard enteral nutrition; Dietary Supplement: restricted enteral nutrition

• Registration Number: NCT04005300
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-02
• Primary Completion: 2020-08-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-27
• Last Update Posted: 2020-12-29
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard calorie feeding group	standard enteral nutrition	Enteral nutrition was fed at 500-750kcal/d for the first three days before identifying the refeeding syndrome
low calorie feeding group	restricted enteral nutrition	Enteral nutrition was fed at 10-20kcal/kg/d for the first three days before identifying the refeeding syndrome

Primary Outcome Measures

Name	Time	Method
The best diagnostic criteria for refeeding syndrome	1 month mortality and the duration of mechanical ventilation	Evaluate the best timing for intervention according to the lowest and the decline of serum phosphate
the incidence of refeeding syndrome	3 day after treated with nutrition	only according to serum phosphate standard

Secondary Outcome Measures

Name	Time	Method
duration of mechanical ventilation	30 days	The duration of mechanical ventilation in General ICU of our department in the same time admitted to ICU
survival rate	28 days	including discharge from hospital and ICU
occurrence of complications	7 days	including feeding intolerance, electrolyte disturbance

Trial Locations

Locations (1)

Second affiliated hospital, Zhejiang university school of medicine; 🇨🇳 Hangzhou, Zhejiang, China