Evaluation of the Efficacy of Nutritional Risk Screening Tests, NRS 2002 and SGA, to Identifying Malnourished Patients

"Evaluation of the Efficacy of Two Nutritional Risk Screening Tests, Nutritional Risk Screening 2002 (NRS 2002) and Subjective Global Assessment (SGA), to Identifying Malnourished or at Risk of Malnutrition Hospital Patients"

In several hospital clinical trials, the nutritional intervention has been proven to be effective in preventing and/or reducing malnutrition. Therefore, a procedure to identify the risk of malnutrition or malnourishment in hospitalized patients is necessary to guarantee an adequate and timely nutritional treatment.

Aims: to compare two validated nutritional screening tools: NRS 2002 and SGA. These are used to identify the risk of malnutrition or malnourishment in hospitalized patients.

Patients and Methods: The study is currently carried out at the Federico II University Hospital of Naples, Italy. The in patients admitted in the Clinical Wards since September 2016 are being evaluated. The two screening test results and the assessment of the patients' parameters are collected within 72 hours following admission. Age, sex, height, weight, Body Mass Index (BMI), calf circumference and dominant hand of the participants are being noted. Venous blood samples are collected for routine biochemistry and inflammatory parameters ; all measurements are determined by routine laboratory methods at the Department of Laboratory Medicine of the University Hospital Federico II, Naples.

Study Overview

• Status: Unknown
• Conditions: Malnutrition

Detailed Description

In several hospital clinical trials, the nutritional intervention has been proven to be effective in preventing and/or reducing malnutrition. Therefore, a procedure to identify the risk of malnutrition or malnourishment in hospitalized patients is necessary to guarantee an adequate and timely nutritional treatment. It is mandatory for clinics and health services to perform the screening test for the evaluation of the nutritional status and need in hospitalized patient.

Aims: The first aim of this study is to compare two validated nutritional screening tools: Nutritional Risk Screening 2002 (NRS 2002) and Subjective Global Assessment (SGA). These are used to identify the risk of malnutrition or malnourishment in hospitalized patients. The second aim is to evaluate possible correlations between the tests score and body composition parameters (phase angle of the Bioelectrical Impedance Analysis, BIA), handgrip strength and biochemical parameters.

Patients and Methods: The study is currently carried out at the Federico II University Hospital of Naples, Italy. The inpatients admitted in the Clinical Wards coming from the Emergency Room of the Hospital since September 2016 are being evaluated. The two screening test results and the assessment of the patients' parameters are collected within 72 hours following admission. The SGA and NRS 2002 are administered separately. Age, sex, height, weight, Body Mass Index (BMI), calf circumference and dominant hand of the participants are being noted. Venous blood samples are collected for routine biochemistry and inflammatory parameters (C-reactive protein, fibrinogen) early in the morning in the fasting state; all measurements are determined by routine laboratory methods at the Department of Laboratory Medicine of the University Hospital Federico II, Naples.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy, 80131
    • Recruiting
    • Fabrizio Pasanisi
    • Contact: Franco Contaldo, MD; Phone Number: 00390817464747; Email: contaldo@unina.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospital Wards inpatients

Description

Inclusion Criteria:

• Age: ≥ 18 years.

Exclusion Criteria:

• Inpatients of the intensive care unit after admission from Emergency Room;
• Pregnancy and breastfeeding.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
malnutrition scored with NRS 2002 questionnaire	scoring scale (units 0-3) : 0 = nourished patient; 1 = mild malnutrition, 2 = moderate malnutrition, 3 = severe malnutrition	5 minutes
malnutrition scored with SGA questionnaire	scoring scale (units a-c) : a = nourished patient; b = mildly malnourished; c = severely malnourished	5 minutes

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2016
• Primary Completion (ACTUAL): January 1, 2018
• Study Completion (ANTICIPATED): September 1, 2018

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (ACTUAL): January 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 22, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 164/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No