Individualized NUTRItional RISK and Oriented Nutritional Support

NCT06590350 | Active Not Recruiting

• 1 other identifier: 6407 - NUTRISKO
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate whether, in patients who are given early nutritional counseling, there is a reduction in the length of hospitalization and the rate of nosocomial infections, resulting in a decrease in inpatient costs, compared with patients who do not benefit from this intervention.

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

• Difference in the duration of hospitalization

  Difference in the overall length of stay in patients at risk of malnutrition (NRS-2002 ≥ 3) who received nutrition counseling within 72 hours of ward admission compared to the group of patients at risk who did not receive counseling within 72 hours.

  12 months

Secondary Outcomes (3)

• Differences in the number of infectious complications

  12 months

• Frequency of adherence to diet and AFMS proposed at visit

  12 months

• Differences in hospitalization costs for the healthcare

  12 months

Study Arms (2)

Cohort who received clinical nutrition counseling <72 hours

Patients at risk of malnutrition who received clinical nutrition counseling within 72 hours.

Other: Clinical nutrition counseling

Cohort who did NOT received clinical nutrition counseling <72 hours

Patients at risk of malnutrition who did NOT receive clinical nutrition counseling within 72 hours.

Other: Clinical nutrition counseling

Interventions

Clinical nutrition counseling OTHER

In the first phase, all patients admitted to the Departmental Simple Operating Unit Admission Room of Policlinico Universitario A. Gemelli will be screened for NRS-2002 upon admission. Only patients with NRS-2002 ≥ 3 will subsequently be tracked via the Foundation's computer system (TrackCare®). The patients will be managed by caregivers who may spontaneously request nutritional counseling, as is currently the case. Patient data (laboratory tests, medical history, reason for admission, any instrumental test reports) and clinical outcomes (average length of hospitalization, complications, antibiotic therapy use, intensive care admission, mortality, re-hospitalization within 30 days) will be obtained from the Foundation's computer system (TrackCare®) and recorded in a dedicated Excel® spreadsheet. Costs related to hospitalization and management of any complications will also be assessed.

Cohort who did NOT received clinical nutrition counseling <72 hours; Cohort who received clinical nutrition counseling <72 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients at risk of malnutrition by default (NRS-2002 ≥3) admitted to the Admission Room Departmental Simple Operating Unit of the A. Gemelli Polyclinic Foundation in Rome.

You may qualify if:

• Age \>18 years
• NRS-2002 ≥3
• Length of stay \> 4 days
• Informed consent to participate in the study

You may not qualify if:

• NRS-2002 \<3
• Length of stay \< or = 4 days
• Absence of informed consent

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Emanuele Rinninella

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Emanuele Rinninella

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: September 19, 2024
• Study Start: June 4, 2024
• Primary Completion: December 31, 2024
• Study Completion: October 1, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

IT (1)