- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07620106
Nutritional Support in Hospitalized Patients (COCONUT)
3. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
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
Observasjonsmessig
Registrering (Faktiske)
578
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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BA
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Bari, BA, Italia, 70124
- Polyclinic University Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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).
Beskrivelse
Inclusion Criteria: Hospitalized patients receiving artificial nutrition -
Exclusion Criteria: Patients on normal oral feeding.
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Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Prevalence of patients receiving artificial nutrition during their hospitalization.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Evaluation of the total amount of calories received
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Protein intake/kg of body weight
Tidsramme: 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).
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Michele Barone, University of Bari
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
10. juni 2024
Primær fullføring (Faktiske)
12. juni 2024
Studiet fullført (Faktiske)
12. juni 2024
Datoer for studieregistrering
Først innsendt
28. april 2026
Først innsendt som oppfylte QC-kriteriene
26. mai 2026
Først lagt ut (Faktiske)
2. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. juni 2026
Sist bekreftet
1. juni 2024
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Policlinico Bari 1698
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
The study was already completed, and all the data will be published.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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