Nutritional Support in Hospitalized Patients (COCONUT)

June 3, 2026 updated by: 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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

578

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BA
      • Bari, BA, Italy, 70124
        • Polyclinic University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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).

Description

Inclusion Criteria: Hospitalized patients receiving artificial nutrition -

Exclusion Criteria: Patients on normal oral feeding.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).
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.
This evaluation was performed at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bari

Investigators

  • Study Chair: Michele Barone, University of Bari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2024

Primary Completion (Actual)

June 12, 2024

Study Completion (Actual)

June 12, 2024

Study Registration Dates

First Submitted

April 28, 2026

First Submitted That Met QC Criteria

May 26, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Policlinico Bari 1698

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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