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Completed

NCT Number: NCT07620106

Nutritional Support in Hospitalized Patients

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.

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Key information

Conditions

Malnourished Patients Requiring Artificial Nutritional Support Hyperphagia Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Polyclinic University Hospital

Bari, BA, 70124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Hospitalized patients receiving artificial nutrition -

Exclusion criteria

Patients on normal oral feeding.

-

Treatment and study plan

Primary outcomes

  1. Prevalence of patients receiving artificial nutrition during their hospitalization.

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

Secondary outcomes

  1. Evaluation of the total amount of calories received

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

    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.

Other outcomes

  1. Protein intake/kg of body weight

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

    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.

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

    Time frame: This evaluation was performed at baseline

    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.

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Registry information

Official study title

Nutrition Day: Prevalenza Della Nutrizione Artificiale Nei Pazienti Ospedalizzati e Appropriatezza Prescrittiva a Supporto Della Valutazione Dei Costi e Della Programmazione Dei Consumi.

Acronym: COCONUT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 2, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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