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

Primary Purpose

Critical Illness

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
standard enteral nutrition
restricted enteral nutrition
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Critical Illness focused on measuring Refeeding syndrome, Enteral nutrition, Critical illness

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Second affiliated hospital, Zhejiang university school of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

No Intervention

No Intervention

Arm Label

low calorie feeding group

standard calorie feeding group

RFS group

nRFS group

Arm Description

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

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

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.

It is not up to the RFS definition

Outcomes

Primary Outcome Measures

The best diagnostic criteria for refeeding syndrome
Evaluate the best timing for intervention according to the lowest and the decline of serum phosphate
the incidence of refeeding syndrome
only according to serum phosphate standard

Secondary Outcome Measures

duration of mechanical ventilation
The duration of mechanical ventilation in General ICU of our department in the same time admitted to ICU
survival rate
including discharge from hospital and ICU
occurrence of complications
including feeding intolerance, electrolyte disturbance

Full Information

First Posted
July 1, 2019
Last Updated
December 27, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04005300
Brief Title
Application of Prophylactic Low Calorie Feeding in Critically Ill Patients With High-risk Refeeding Syndrome
Official Title
Application of Prophylactic Low Calorie Feeding in Critically Ill Patients With High-risk Refeeding Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
August 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Refeeding syndrome, Enteral nutrition, Critical illness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low calorie feeding group
Arm Type
Experimental
Arm Description
Enteral nutrition was fed at 10-20kcal/kg/d for the first three days before identifying the refeeding syndrome
Arm Title
standard calorie feeding group
Arm Type
Active Comparator
Arm Description
Enteral nutrition was fed at 500-750kcal/d for the first three days before identifying the refeeding syndrome
Arm Title
RFS group
Arm Type
No Intervention
Arm Description
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.
Arm Title
nRFS group
Arm Type
No Intervention
Arm Description
It is not up to the RFS definition
Intervention Type
Dietary Supplement
Intervention Name(s)
standard enteral nutrition
Intervention Description
Enteral nutrition was treated within 48 hours after ICU and the calories were 500-750kcal/d
Intervention Type
Dietary Supplement
Intervention Name(s)
restricted enteral nutrition
Intervention Description
Enteral nutrition was treated within 48 hours after ICU and the calories were 10-20kcal/kg/d for 3 days
Primary Outcome Measure Information:
Title
The best diagnostic criteria for refeeding syndrome
Description
Evaluate the best timing for intervention according to the lowest and the decline of serum phosphate
Time Frame
1 month mortality and the duration of mechanical ventilation
Title
the incidence of refeeding syndrome
Description
only according to serum phosphate standard
Time Frame
3 day after treated with nutrition
Secondary Outcome Measure Information:
Title
duration of mechanical ventilation
Description
The duration of mechanical ventilation in General ICU of our department in the same time admitted to ICU
Time Frame
30 days
Title
survival rate
Description
including discharge from hospital and ICU
Time Frame
28 days
Title
occurrence of complications
Description
including feeding intolerance, electrolyte disturbance
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
kongmiao lu, master
Phone
18268061252
Email
lukongmiao123@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
man huang, phD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
man huang, phD
Organizational Affiliation
Second affiliated hospital, Zhejiang university school of medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
yunlong wu, master
Organizational Affiliation
Second affiliated hospital, Zhejiang university school of medicine
Official's Role
Study Director
Facility Information:
Facility Name
Second affiliated hospital, Zhejiang university school of medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lu kongmiao, master
Phone
018268061252
Email
lukongmiao123@163.com
First Name & Middle Initial & Last Name & Degree
lu kongmiao

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://pan.baidu.com/s/1nmmz9g9-cQrKkpJxVyglog
Citations:
PubMed Identifier
26597128
Citation
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.
Results Reference
background
PubMed Identifier
23315514
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):e002173. doi: 10.1136/bmjopen-2012-002173.
Results Reference
background
Links:
URL
http://linkinghub.elsevier.com/retrieve/pii/S2213-2600(15)00418-X
Description
Restricted versus continued standard caloric intake during the management of refeeding syndrome in critically ill adults
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3549252/
Description
Occurrence of refeeding syndrome in adults started on artificial nutrition support

Learn more about this trial

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

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