- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07620106
Nutritional Support in Hospitalized Patients (COCONUT)
Nutrition Day: Prevalenza Della Nutrizione Artificiale Nei Pazienti Ospedalizzati e Appropriatezza Prescrittiva a Supporto Della Valutazione Dei Costi e Della Programmazione Dei Consumi.
Studieoversigt
Status
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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BA
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Bari, BA, Italien, 70124
- Polyclinic University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria: To calculate the prevalence of hospitalized patients receiving artificial nutrition, all patients admitted to medical or surgical wards or to the intensive care unit were enrolled. For patients receiving artificial nutrition, the interval from hospital admission to initiation of the nutritional treatment, the type of nutritional treatment (enteral or parenteral), and the protein/caloric support received were evaluated.
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Exclusion Criteria: None.
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Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Michele Barone, University of Bari
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Policlinico Bari 1698
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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