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NCT03365258 Clinical 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

Critical Illness Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03365258
Other study ID # CF17249A
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 28, 2017
Est. completion date May 31, 2020

Study information
Verified date February 2020
Source Taichung Veterans General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date May 31, 2020
Est. primary completion date May 31, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 100 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Trophic feeding
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.
• volume-based feeding
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

Locations
Country Name City State
Taiwan ??? Taichung City ???

Sponsors (1)
Lead Sponsor Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary In-hospital mortality mortality or discharge 90 days
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