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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04005300
• Other study ID #: refeeding syndrome
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: August 1, 2021

Study information

• Verified date: December 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: kongmiao lu, master
• Phone: 18268061252
• Email: lukongmiao123[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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;

Related Conditions & MeSH terms

• Critical Illness
• Refeeding Syndrome

Intervention

Dietary Supplement:
• standard enteral nutrition
Enteral nutrition was treated within 48 hours after ICU and the calories were 500-750kcal/d
• restricted enteral nutrition
Enteral nutrition was treated within 48 hours after ICU and the calories were 10-20kcal/kg/d for 3 days

Locations

Country	Name	City	State
China	Second affiliated hospital, Zhejiang university school of medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (2)

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

Outcome

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

External Links

•   Occurrence of refeeding syndrome in adults started on artificial nutrition support
•   Restricted versus continued standard caloric intake during the management of refeeding syndrome in critically ill adults