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

February 5, 2020 updated by: Wang, Chen-Yu, Taichung Veterans General Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • 台中市
      • Taichung City, 台中市, Taiwan, 433
        • Recruiting
        • 王振宇
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: High Nutritional Risk
modified NUTRIC score ≥ 5
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.
Dietary supplement: 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
Other Names:
  • Full caloric feeding
OTHER: Low Nutritional Risk
modified NUTRIC score < 5
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.
Dietary supplement: 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
Other Names:
  • Full caloric feeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital mortality
Time Frame: 90 days
mortality or discharge
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 28, 2017

Primary Completion (ANTICIPATED)

May 31, 2020

Study Completion (ANTICIPATED)

May 31, 2020

Study Registration Dates

First Submitted

November 28, 2017

First Submitted That Met QC Criteria

December 2, 2017

First Posted (ACTUAL)

December 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CF17249A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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