Clinical trial NCT03408067: Evaluation of the Efficacy of Nutritional Risk Screening Tests, NRS 2002 and SGA, to Identifying Malnourished Patients
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"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malnutrition
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital Wards inpatients

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.

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.

Eligibility criteria: Inclusion Criteria:

* Age: ≥ 18 years.

Exclusion Criteria:

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

Primary outcomes:
measure: malnutrition scored with NRS 2002 questionnaire
timeFrame: 5 minutes
measure: malnutrition scored with SGA questionnaire
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Fabrizio Pasanisi
Study officials:
References: