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Nutritional Support in Hospitalized Patients (COCONUT)
3 juni 2026 bijgewerkt door: Michele Barone, University of Bari
Nutrition Day: Prevalenza Della Nutrizione Artificiale Nei Pazienti Ospedalizzati e Appropriatezza Prescrittiva a Supporto Della Valutazione Dei Costi e Della Programmazione Dei Consumi.
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.
Studie Overzicht
Toestand
Voltooid
Gedetailleerde beschrijving
Despite detailed recommendations provided by international scientific societies, numerous studies highlight substantial variability and deficiencies in clinical practice, notably delays in initiating artificial nutrition (AN), inadequate caloric and protein dosing, and disparities in treatment across patient groups.
Unfortunately, applying the general recommendations to nutritional therapy for polymorbid patients is particularly challenging for healthcare providers without specific nutrition training, as disease-specific quantitative and qualitative nutritional requirements must be considered.
In this report, we present results obtained from data collected on hospitalized patients undergoing AN across 35 medical and surgical wards and the intensive care unit of a university hospital in Southern Italy.
In all these cases, the decisions regarding the type (enteral/parenteral) and the intensity (calories/proteins) of the nutritional interventions observed were made by the physicians working on the wards.
This study describes the application of AN in real-world hospital settings, identifying the main critical issues and suggesting possible interventions to improve clinical practice.
Studietype
Observationeel
Inschrijving (Werkelijk)
578
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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BA
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Bari, BA, Italië, 70124
- Polyclinic University Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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).
Beschrijving
Inclusion Criteria: Hospitalized patients receiving artificial nutrition -
Exclusion Criteria: Patients on normal oral feeding.
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Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Prevalence of patients receiving artificial nutrition during their hospitalization.
Tijdsspanne: Baseline evaluation was performed for all patients on the same day, which corresponded to a variable time from the beginning of hospitalization.
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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.
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Baseline evaluation was performed for all patients on the same day, which corresponded to a variable time from the beginning of hospitalization.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Evaluation of the total amount of calories received
Tijdsspanne: Baseline evaluation was performed for all patients on the same day, which corresponded to a variable time from the beginning of hospitalization.
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The total caloric intake received by each patient was calculated based on the characteristics of nutritional parenteral and enteral products and the duration of their infusion.
The appropriateness of the caloric intake was calculated using the most accurate prediction formula suggested for a specific body mass index (BMI) range.
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Baseline evaluation was performed for all patients on the same day, which corresponded to a variable time from the beginning of hospitalization.
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Protein intake/kg of body weight
Tijdsspanne: Baseline evaluation was performed for all patients on the same day, which corresponded to a variable time from the beginning of hospitalization.
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Patients admitted to the intensive care unit were fed by enteral nutrition and received only 0.41 ± 0.15 g/kg b.w.
Patients receiving parenteral nutrition had a protein intake ranging from 0.55 ± 0.15 to 0.70 ± 0.17 g/kg of body weight.
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Baseline evaluation was performed for all patients on the same day, which corresponded to a variable time from the beginning of hospitalization.
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The median time elapsed between hospital admission and the initiation of artificial nutrition (AN).
Tijdsspanne: This evaluation was performed at baseline
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The median time to initiate AN following hospital admission was 3 days (IQR 0-13.5 days).
In detail, ICU patients received AN after 1 day (IQR 0-2), whereas patients in other wards received saline solutions with or without glucose for 5 days (IQR 0-16) after admission before commencing AN.
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This evaluation was performed at baseline
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie stoel: Michele Barone, University of Bari
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
10 juni 2024
Primaire voltooiing (Werkelijk)
12 juni 2024
Studie voltooiing (Werkelijk)
12 juni 2024
Studieregistratiedata
Eerst ingediend
28 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
26 mei 2026
Eerst geplaatst (Werkelijk)
2 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
5 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
3 juni 2026
Laatst geverifieerd
1 juni 2024
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Policlinico Bari 1698
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
The study was already completed, and all the data will be published.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .