NCT07620106

Brief Summary

To evaluate the prevalence of hospitalized patients who receive artificial nutrition, the type of patients who resort to artificial nutrition, the appropriateness of the latter in terms of specificity with respect to the clinical condition, and the adequacy of the caloric-protein intake provided to the patient.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
578

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2024

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
Last Updated

June 5, 2026

Status Verified

June 1, 2024

Enrollment Period

2 days

First QC Date

April 28, 2026

Last Update Submit

June 3, 2026

Conditions

Keywords

malnutritionnutritional supportenteral nutritionparenteral nutrition

Outcome Measures

Primary Outcomes (1)

  • Prevalence of patients receiving artificial nutrition during their hospitalization.

    Among the 578 hospitalized patients, 56 (9.7%; 30 males, 26 females), with a mean age of 67.1 ± 11.6 years, were receiving artificial nutrition (AN). The modalities of AN administration were as follows: total parenteral nutrition (TPN) in 39 patients, enteral nutrition (EN) in 16 patients, and EN plus supplemental parenteral nutrition (SPN) in 1 patient.

    Baseline evaluation was performed for all patients on the same day, which corresponded to a variable time from the beginning of hospitalization.

Secondary Outcomes (1)

  • Evaluation of the total amount of calories received

    Baseline evaluation was performed for all patients on the same day, which corresponded to a variable time from the beginning of hospitalization.

Other Outcomes (2)

  • Protein intake/kg of body weight

    Baseline evaluation was performed for all patients on the same day, which corresponded to a variable time from the beginning of hospitalization.

  • The median time elapsed between hospital admission and the initiation of artificial nutrition (AN).

    This evaluation was performed at baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This observational, cross-sectional study evaluated the prevalence of patients receiving artificial nutrition and the appropriateness of this treatment at the Bari Polyclinic University Hospital. All patients were allocated to 35 different medical and surgical wards or the intensive care unit (ICU).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Polyclinic University Hospital

Bari, BA, 70124, Italy

Location

Related Publications (9)

  • Jensen GL, Cederholm T, Correia MITD, Gonzalez MC, Fukushima R, Higashiguchi T, de Baptista GA, Barazzoni R, Blaauw R, Coats AJS, Crivelli A, Evans DC, Gramlich L, Fuchs-Tarlovsky V, Keller H, Llido L, Malone A, Mogensen KM, Morley JE, Muscaritoli M, Nyulasi I, Pirlich M, Pisprasert V, de van der Schueren M, Siltharm S, Singer P, Tappenden KA, Velasco N, Waitzberg DL, Yamwong P, Yu J, Compher C, Van Gossum A. GLIM Criteria for the Diagnosis of Malnutrition: A Consensus Report From the Global Clinical Nutrition Community. JPEN J Parenter Enteral Nutr. 2019 Jan;43(1):32-40. doi: 10.1002/jpen.1440. Epub 2018 Sep 2.

    PMID: 30175461BACKGROUND
  • Totland TH, Krogh HW, Smedshaug GB, Tornes RA, Bye A, Paur I. Harmonization and standardization of malnutrition screening for all adults - A systematic review initiated by the Norwegian Directorate of Health. Clin Nutr ESPEN. 2022 Dec;52:32-49. doi: 10.1016/j.clnesp.2022.09.028. Epub 2022 Oct 2.

    PMID: 36513471BACKGROUND
  • Amato V, De Caprio C, Santarpia L, De Rosa A, Bongiorno C, Stella G, De Rosa E, Iacone R, Scanzano C, Pasanisi F, Contaldo F. Time trend prevalence of artificial nutrition counselling in a university hospital. Nutrition. 2019 Feb;58:181-186. doi: 10.1016/j.nut.2018.08.014. Epub 2018 Aug 24.

    PMID: 30504009BACKGROUND
  • Krishnan S, Sytsma T, Wischmeyer PE. Addressing the Urgent Need for Clinical Nutrition Education in PostGraduate Medical Training: New Programs and Credentialing. Adv Nutr. 2024 Nov;15(11):100321. doi: 10.1016/j.advnut.2024.100321. Epub 2024 Oct 16.

    PMID: 39424228BACKGROUND
  • Wunderle C, Gomes F, Schuetz P, Stumpf F, Austin P, Ballesteros-Pomar MD, Cederholm T, Fletcher J, Laviano A, Norman K, Poulia KA, Schneider SM, Stanga Z, Bischoff SC. ESPEN practical guideline: Nutritional support for polymorbid medical inpatients. Clin Nutr. 2024 Mar;43(3):674-691. doi: 10.1016/j.clnu.2024.01.008. Epub 2024 Jan 24.

    PMID: 38309229BACKGROUND
  • Correia MI, Hegazi RA, Higashiguchi T, Michel JP, Reddy BR, Tappenden KA, Uyar M, Muscaritoli M. Evidence-based recommendations for addressing malnutrition in health care: an updated strategy from the feedM.E. Global Study Group. J Am Med Dir Assoc. 2014 Aug;15(8):544-50. doi: 10.1016/j.jamda.2014.05.011. Epub 2014 Jul 2.

    PMID: 24997720BACKGROUND
  • Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.

    PMID: 30348463BACKGROUND
  • Bolado Jimenez C, Fernadez Ovalle H, Munoz Moreno MF, Aller de la Fuente R, de Luis Roman DA. Undernutrition measured by the Mini Nutritional Assessment (MNA) test and related risk factors in older adults under hospital emergency care. Nutrition. 2019 Oct;66:142-146. doi: 10.1016/j.nut.2019.04.005. Epub 2019 May 10.

    PMID: 31279180BACKGROUND
  • Pirlich M, Schutz T, Norman K, Gastell S, Lubke HJ, Bischoff SC, Bolder U, Frieling T, Guldenzoph H, Hahn K, Jauch KW, Schindler K, Stein J, Volkert D, Weimann A, Werner H, Wolf C, Zurcher G, Bauer P, Lochs H. The German hospital malnutrition study. Clin Nutr. 2006 Aug;25(4):563-72. doi: 10.1016/j.clnu.2006.03.005. Epub 2006 May 15.

    PMID: 16698132BACKGROUND

MeSH Terms

Conditions

MalnutritionHyperphagia

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michele Barone

    University of Bari

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 28, 2026

First Posted

June 2, 2026

Study Start

June 10, 2024

Primary Completion

June 12, 2024

Study Completion

June 12, 2024

Last Updated

June 5, 2026

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

The study was already completed, and all the data will be published.

Locations