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
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2017
CompletedFirst Posted
Study publicly available on registry
December 7, 2017
CompletedStudy Start
First participant enrolled
December 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2020
CompletedFebruary 7, 2020
February 1, 2020
2.4 years
November 28, 2017
February 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
In-hospital mortality
mortality or discharge
90 days
Study Arms (2)
High Nutritional Risk
OTHERmodified NUTRIC score ≥ 5
Low Nutritional Risk
OTHERmodified NUTRIC score \< 5
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- \. 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
You may not qualify if:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
王振宇
Taichung, 台中市, 433, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Medical Intensive Care Unit
Study Record Dates
First Submitted
November 28, 2017
First Posted
December 7, 2017
Study Start
December 28, 2017
Primary Completion
May 31, 2020
Study Completion
May 31, 2020
Last Updated
February 7, 2020
Record last verified: 2020-02