Back to resultsThe Effect of Applying Modified NUTRIC Scoring System to Evaluate the Nutrition Risk and Giving Different Types of Nutritional Support on Clinical Outcomes in Critically Ill Patients
Primary Purpose
Critical Illness
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Trophic feeding
volume-based feeding
Sponsored by
About this trial
This is an interventional other trial for Critical Illness
Eligibility Criteria
Inclusion Criteria:
- 1. Medical intensive care unit patients 2. age elder than 20 years old 3. Intubated with ventilator support patients 4. Predicted ICU stay longer than 72 hours
Exclusion Criteria:
- 1. NPO patients 2. Contraindication for enteral feeding 3. TPN use 4. Upper or lower GI bleeding patients 5. Feeding with gastrostomy or Jejunostomy patients 6. Metoclopramide related EPS or Torsades de pointes history
Sites / Locations
- 王振宇Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
High Nutritional Risk
Low Nutritional Risk
Arm Description
modified NUTRIC score ≥ 5
modified NUTRIC score < 5
Outcomes
Primary Outcome Measures
In-hospital mortality
mortality or discharge
Secondary Outcome Measures
Full Information
NCT ID
NCT03365258
First Posted
November 28, 2017
Last Updated
February 5, 2020
Sponsor
Taichung Veterans General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03365258
Brief Title
The Effect of Applying Modified NUTRIC Scoring System to Evaluate the Nutrition Risk and Giving Different Types of Nutritional Support on Clinical Outcomes in Critically Ill Patients
Official Title
The Effect of Applying Modified NUTRIC Scoring System to Evaluate the Nutrition Risk and Giving Different Types of Nutritional Support on Clinical Outcomes in Critically Ill Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 28, 2017 (Actual)
Primary Completion Date
May 31, 2020 (Anticipated)
Study Completion Date
May 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taichung Veterans General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Malnutrition is very common in critically ill patients. It is quite important to evaluate nutritional status precisely. Heyland et al firstly reported NUTRIC score including age, APACHE II score, SOFA score, number of commorbidities, days from hospital to ICU admission and IL-6. Because the IL-6 is not routinely checked at ICU. A modified NUTRIC score without IL-6 is more practical. Previous studies showed lower in-hospital mortality in higher nutritional risk patients with higher caloric intake compared with lower caloric intake. However, there is still controversial regarding the in-hospital mortality between full caloric feeding and permissive underfeeding in critically ill patients. Herein the investigators conduct a study to investigate what kinds of nutritional supplements will decrease in-hospital mortality in different nutritional risk patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High Nutritional Risk
Arm Type
Other
Arm Description
modified NUTRIC score ≥ 5
Arm Title
Low Nutritional Risk
Arm Type
Other
Arm Description
modified NUTRIC score < 5
Intervention Type
Dietary Supplement
Intervention Name(s)
Trophic feeding
Intervention Description
Non-blind to randomize to trophic feeding group and volume based feeding group in the first six days (Day 0->Day 6). The definition of trophic feeding is continue feeding with feeding rate: 20 kcal/hr.
Intervention Type
Dietary Supplement
Intervention Name(s)
volume-based feeding
Other Intervention Name(s)
Full caloric feeding
Intervention Description
Non-blind to randomize to trophic feeding group and volume based feeding group in the first six days (Day 0->Day 6). The definition Volume-based feeding also use continue feeding by feeding protocol
Primary Outcome Measure Information:
Title
In-hospital mortality
Description
mortality or discharge
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Medical intensive care unit patients 2. age elder than 20 years old 3. Intubated with ventilator support patients 4. Predicted ICU stay longer than 72 hours
Exclusion Criteria:
1. NPO patients 2. Contraindication for enteral feeding 3. TPN use 4. Upper or lower GI bleeding patients 5. Feeding with gastrostomy or Jejunostomy patients 6. Metoclopramide related EPS or Torsades de pointes history
Facility Information:
Facility Name
王振宇
City
Taichung City
State/Province
台中市
ZIP/Postal Code
433
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
振宇 王, MD
Phone
886-4-23592525
Ext
3167
Email
chestmen@gmail.com
First Name & Middle Initial & Last Name & Degree
CHEN-YU WANG, MD
Phone
886-4-23592525
Ext
3167
Email
chestmen@gmail.com
12. IPD Sharing Statement
Learn more about this trial
The Effect of Applying Modified NUTRIC Scoring System to Evaluate the Nutrition Risk and Giving Different Types of Nutritional Support on Clinical Outcomes in Critically Ill Patients
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