Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-02-01 @ 7:05 AM
Study NCT ID:
NCT06590350
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-13
First Post:
2024-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individualized NUTRItional RISK and Oriented Nutritional Support
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Study Overview
Official Title:
Individualized NUTRItional RISK and Oriented Nutritional Support
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NUTRISKO
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.
Detailed Description:
Patients admitted from the date following the date of approval of the protocol for the following 12 months will be enrolled at the Departmental Simple Operating Unit Admission Room of the Policlinico Universitario A. Gemelli and who have undergone NRS-2002 screening.
Data only of patients with NRS-2002 \> 3 admitted will be considered and extracted via the Foundation's computer system (Trackcare).
Patients will be managed by caregivers who spontaneously request (as is the case to date) nutritional counseling. Therefore, the study will not change current clinical practice.
Two cohorts will be formed and compared:
Cohort 1: patients at risk of malnutrition (NRS-2002 ≥ 3) who received clinical nutrition counseling within 72 hours of ward admission.
Cohort 2: patients at risk of malnutrition (NRS-2002 ≥ 3) who did NOT receive clinical nutrition counseling beyond 72 hours after ward admission.
Currently, at Fondazione Policlinico Universitario A. Gemelli, the Clinical Nutrition Unit is approached on an ad hoc basis by the individual ward attending physician, without a specific procedure: the physician calls in Clinical Nutrition specialists for consultation if in his or her judgment the patient needs nutritional support. The formation of the two cohorts will be entirely spontaneous, that is, according to current clinical practice, given by the judgment of the ward treating physician. In a spontaneous manner, two cohorts will be formed among patients at risk of malnutrition (NRS-2002 ≥ 3), one of which will have received specialized nutritional support within 72 hours, the other will not. Only patients at risk of malnutrition will be tracked, highlighting outcomes among those in this category who received the targeted intervention at the appropriate times, versus those who did not. The enrollment department is the same for all patients.
Data only of patients with NRS-2002 \> 3 admitted will be considered and extracted via the Foundation's computer system (Trackcare).
Patients will be managed by caregivers who spontaneously request (as is the case to date) nutritional counseling. Therefore, the study will not change current clinical practice.
Two cohorts will be formed and compared:
Cohort 1: patients at risk of malnutrition (NRS-2002 ≥ 3) who received clinical nutrition counseling within 72 hours of ward admission.
Cohort 2: patients at risk of malnutrition (NRS-2002 ≥ 3) who did NOT receive clinical nutrition counseling beyond 72 hours after ward admission.
Currently, at Fondazione Policlinico Universitario A. Gemelli, the Clinical Nutrition Unit is approached on an ad hoc basis by the individual ward attending physician, without a specific procedure: the physician calls in Clinical Nutrition specialists for consultation if in his or her judgment the patient needs nutritional support. The formation of the two cohorts will be entirely spontaneous, that is, according to current clinical practice, given by the judgment of the ward treating physician. In a spontaneous manner, two cohorts will be formed among patients at risk of malnutrition (NRS-2002 ≥ 3), one of which will have received specialized nutritional support within 72 hours, the other will not. Only patients at risk of malnutrition will be tracked, highlighting outcomes among those in this category who received the targeted intervention at the appropriate times, versus those who did not. The enrollment department is the same for all patients.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: