We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prognostic Value of the SGA and NUTRIC in the ICU

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03176602
First Posted: June 5, 2017
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Flinders University
National University, Singapore
Information provided by (Responsible Party):
JurongHealth
  Purpose

There are two nutrition assessment tools that are commonly used in the ICU, namely the Subjective Global Assessment (SGA) and Modified Nutrition Risk in Critically Ill Score (mNUTRIC). It has been proposed that both assessments should be performed in the ICU but their combined prognostic ability has not been adequately assessed.

This study aimed to: 1) determine the agreement between SGA and mNUTRIC scores, and 2) quantify their utility in discriminating and quantifying hospital mortality risk both independently and in combination.


Condition
Critical Illness Malnutrition

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Combining Two Commonly Adopted Nutrition Instruments in the Critical Care Setting is Superior to Administering Either One Alone

Further study details as provided by JurongHealth:

Primary Outcome Measures:
  • Hospital mortality [ Time Frame: Up to one year after admission to the ICU ]
    All patients will be followed until discharge or death


Enrollment: 503
Actual Study Start Date: August 1, 2015
Study Completion Date: October 31, 2016
Primary Completion Date: October 31, 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
All patients admitted to the ICU
All patients ≥ 18 years old who had ≥ 24 hours length of stay in the ICU

Detailed Description:

This prospective observational study will be conducted in a 35-bed mixed ICU in Ng Teng Fong General Hospital, and all the intensivists and nurses will be blinded to the objectives of the study. All patients admitted to the ICU will be consecutively included in the study. For patients readmitted to the ICU during the same hospitalisation, only data from the first admission will be collected.

As per routine care, all patients will have their nutritional status assessed by the dietitian within 48 hours of ICU admission. Information required for the nutritional assessment (SGA) will be obtained from the patients or their main care givers, and nutritional status will be dichotomized into well-nourished and malnourished.

The electronic medical records automatically and prospectively collects all data required to calculate the mNUTRIC. At the end of the study, the mNUTRIC will be retrospectively calculated. Patients with values of "0-4" will be classified as low-mNUTRIC and "5-9" as high-mNUTRIC.

The primary outcome will be hospital mortality and all patients will be followed until discharge or death, for up to one year after admission to the ICU.

Agreement and mortality discriminative value (i.e. discrimination) of the 2-category classification of mNUTRIC (Low- and high-mNUTRIC) and SGA (SGA-A and SGA-B/C) will be assessed by Kappa statistics and C-statistics respectively.

A multivariate logistic regression will be used to generate the adjusted odds ratios that quantify the association between high-mNUTRIC, malnutrition, and their combination (mNUTRIC ≥ 5 and SGA-B/C) with hospital mortality.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All patients admitted to the ICU between August-2015 and October-2016 will be enrolled.
Criteria

Inclusion Criteria:

  • ≥ 18 years old who had ≥ 24 hours length of stay in the ICU
  • received a nutrition assessment (SGA) from a dietitian within 48 hours of admission to the ICU

Exclusion Criteria:

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: JurongHealth
ClinicalTrials.gov Identifier: NCT03176602     History of Changes
Other Study ID Numbers: 2014/00878/1
First Submitted: June 2, 2017
First Posted: June 5, 2017
Last Update Posted: June 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by JurongHealth:
Subjective Global Assessment
Nutrition Risk in Critically ill Score
Critical Illness

Additional relevant MeSH terms:
Malnutrition
Critical Illness
Nutrition Disorders
Disease Attributes
Pathologic Processes