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

NCT04005300 | Unknown DMC

• 1 other identifier: refeeding syndrome
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

Refeeding syndrome; Enteral nutrition; Critical illness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• duration of mechanical ventilation

  30 days

• survival rate

  28 days

• occurrence of complications

  7 days

Study Arms (4)

low calorie feeding group

EXPERIMENTAL

Enteral nutrition was fed at 10-20kcal/kg/d for the first three days before identifying the refeeding syndrome

Dietary Supplement: restricted enteral nutrition

standard calorie feeding group

ACTIVE COMPARATOR

Enteral nutrition was fed at 500-750kcal/d for the first three days before identifying the refeeding syndrome

Dietary Supplement: standard enteral nutrition

RFS group

NO INTERVENTION

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.

nRFS group

NO INTERVENTION

It is not up to the RFS definition

Interventions

standard enteral nutrition DIETARY_SUPPLEMENT

Enteral nutrition was treated within 48 hours after ICU and the calories were 500-750kcal/d

standard calorie feeding group

restricted enteral nutrition DIETARY_SUPPLEMENT

Enteral nutrition was treated within 48 hours after ICU and the calories were 10-20kcal/kg/d for 3 days

low calorie feeding group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second affiliated hospital, Zhejiang university school of medicine

Hangzhou, Zhejiang, 310052, China

RECRUITING

Related 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.

  PMID: 26597128 BACKGROUND

• 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.

  PMID: 23315514 BACKGROUND

Related 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

MeSH Terms

Conditions

Critical Illness; Refeeding Syndrome

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• man huang, phD

  Second affiliated hospital, Zhejiang university school of medicine

  PRINCIPAL INVESTIGATOR

• yunlong wu, master

  Second affiliated hospital, Zhejiang university school of medicine

  STUDY DIRECTOR

Central Study Contacts

kongmiao lu, master

CONTACT

18268061252; lukongmiao123@163.com

man huang, phD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 2, 2019
• Study Start: July 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2021
• Last Updated: December 29, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: One year after the article was published, and the opening lasted for one year
• Access Criteria: any study about refeeding syndrome

Locations

CN (1)