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

• ClinicalTrials.gov Identifier: NCT03408067
• Recruitment Status: Unknown
• First Posted: January 23, 2018
• Last Update Posted: January 23, 2018
• Sponsor: Federico II University
• Information provided by (Responsible Party): Fabrizio Pasanisi, Federico II University

Study Description

Brief Summary:

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.

Condition or disease
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 Design

• Study Type: Observational
• Estimated Enrollment: 200 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: "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"
• Actual Study Start Date: September 2016
• Actual Primary Completion Date: January 2018
• Estimated Study Completion Date: September 2018

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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

Biospecimen Retention:   Samples Without DNA

venous blood

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

Study Population

Hospital Wards inpatients

Criteria

Inclusion Criteria:

• Age: ≥ 18 years.

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Fabrizio Pasanisi, MD; 00390817464747; pasanisi@unina.it

Locations

Italy

Fabrizio Pasanisi; Recruiting

Napoli, Italy, 80131

Contact: Franco Contaldo, MD 00390817464747 contaldo@unina.it

Sponsors and Collaborators

Federico II University

More Information

• Responsible Party: Fabrizio Pasanisi, MD, Federico II University
• ClinicalTrials.gov Identifier: NCT03408067
• Other Study ID Numbers: 164/16
• First Posted: January 23, 2018
• Last Update Posted: January 23, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:

Malnutrition; Nutrition Disorders