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

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ClinicalTrials.gov Identifier: NCT04005300
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
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.

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.

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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
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

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



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



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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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005300


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

Locations
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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
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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
Additional Information:
Publications:
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04005300    
Other Study ID Numbers: refeeding syndrome
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
Refeeding syndrome
Enteral nutrition
Critical illness
Additional relevant MeSH terms:
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Refeeding Syndrome
Critical Illness
Pathologic Processes
Disease Attributes
Malnutrition
Nutrition Disorders