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出境医 / 临床实验 / Application of Prophylactic Low Calorie Feeding in Critically Ill Patients With High-risk Refeeding Syndrome

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Critical Illness Dietary Supplement: standard enteral nutrition Dietary Supplement: restricted enteral nutrition Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Application of Prophylactic Low Calorie Feeding in Critically Ill Patients With High-risk Refeeding Syndrome
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2021
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. The best diagnostic criteria for refeeding syndrome [ Time Frame: 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

  2. the incidence of refeeding syndrome [ Time Frame: 3 day after treated with nutrition ]
    only according to serum phosphate standard


Secondary Outcome Measures :
  1. duration of mechanical ventilation [ Time Frame: 30 days ]
    The duration of mechanical ventilation in General ICU of our department in the same time admitted to ICU

  2. survival rate [ Time Frame: 28 days ]
    including discharge from hospital and ICU

  3. occurrence of complications [ Time Frame: 7 days ]
    including feeding intolerance, electrolyte disturbance


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
Contacts and Locations

Contacts
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Contact: kongmiao lu, master 18268061252 lukongmiao123@163.com
Contact: man huang, phD

Locations
Layout table for location information
China, Zhejiang
Second affiliated hospital, Zhejiang university school of medicine Recruiting
Hangzhou, Zhejiang, China, 310052
Contact: lu kongmiao, master    018268061252    lukongmiao123@163.com   
Contact: lu kongmiao         
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
Layout table for investigator information
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
Tracking Information
First Submitted Date  ICMJE July 1, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date December 29, 2020
Actual Study Start Date  ICMJE July 1, 2019
Actual Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • The best diagnostic criteria for refeeding syndrome [ Time Frame: 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 [ Time Frame: 3 day after treated with nutrition ]
    only according to serum phosphate standard
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • duration of mechanical ventilation [ Time Frame: 30 days ]
    The duration of mechanical ventilation in General ICU of our department in the same time admitted to ICU
  • survival rate [ Time Frame: 28 days ]
    including discharge from hospital and ICU
  • occurrence of complications [ Time Frame: 7 days ]
    including feeding intolerance, electrolyte disturbance
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Application of Prophylactic Low Calorie Feeding in Critically Ill Patients With High-risk Refeeding Syndrome
Official Title  ICMJE Application of Prophylactic Low Calorie Feeding in Critically Ill Patients With High-risk Refeeding Syndrome
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Critical Illness
Intervention  ICMJE
  • Dietary Supplement: standard enteral nutrition
    Enteral nutrition was treated within 48 hours after ICU and the calories were 500-750kcal/d
  • 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
Study Arms  ICMJE
  • Experimental: low calorie feeding group
    Enteral nutrition was fed at 10-20kcal/kg/d for the first three days before identifying the refeeding syndrome
    Intervention: Dietary Supplement: restricted enteral nutrition
  • Active Comparator: standard calorie feeding group
    Enteral nutrition was fed at 500-750kcal/d for the first three days before identifying the refeeding syndrome
    Intervention: Dietary Supplement: standard enteral nutrition
  • 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
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). pii: e002173. doi: 10.1136/bmjopen-2012-002173.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2021
Actual Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: kongmiao lu, master 18268061252 lukongmiao123@163.com
Contact: man huang, phD
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04005300
Other Study ID Numbers  ICMJE refeeding syndrome
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: One year after the article was published, and the opening lasted for one year
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: One year after the article was published, and the opening lasted for one year
Access Criteria: any study about refeeding syndrome
URL: https://pan.baidu.com/s/1nmmz9g9-cQrKkpJxVyglog
Responsible Party Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor  ICMJE Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP