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.

Study Overview

• Status: Unknown
• Conditions: Critical Illness
• Intervention / Treatment: Dietary supplement: restricted enteral nutrition; Dietary supplement: standard enteral nutrition

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: kongmiao lu, master; Phone Number: 18268061252; Email: lukongmiao123@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310052
      • Recruiting
      • Second Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: lu kongmiao, master; Phone Number: 018268061252; Email: lukongmiao123@163.com
      • Contact: lu kongmiao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: low calorie feeding group; 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 treated within 48 hours after ICU and the calories were 10-20kcal/kg/d for 3 days
Active Comparator: standard calorie feeding group; Enteral nutrition was fed at 500-750kcal/d for the first three days before identifying the refeeding syndrome	Dietary supplement: standard enteral nutrition; Enteral nutrition was treated within 48 hours after ICU and the calories were 500-750kcal/d
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.
No Intervention: nRFS group; It is not up to the RFS definition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
the incidence of refeeding syndrome	only according to serum phosphate standard	3 day after treated with nutrition

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: 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

Publications and helpful links

General Publications

• 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.
• 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):e002173. doi: 10.1136/bmjopen-2012-002173.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): August 1, 2020
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 27, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Critical illness; Enteral nutrition; Refeeding syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Nutrition Disorders; Malnutrition; Critical Illness; Refeeding Syndrome
• Other Study ID Numbers: refeeding syndrome

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: One year after the article was published, and the opening lasted for one year
• IPD Sharing Time Frame: One year after the article was published, and the opening lasted for one year
• IPD Sharing Access Criteria: any study about refeeding syndrome
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No