Nutrition Practice in Critically Ill Adults (NUTRIENT)

Nutrition Practice in Critically Ill Adults - an Observational Study

To determine the role of nutrition in recovery from critical illness, current practice must first be understood. However, no benchmarking process currently exists for nutrition practice during critical illness, from ICU admission to hospital discharge. This vital gap requires addressing.

The aim of this study is to inform and re-design models of nutrition care and generate research priorities for the future by obtaining data on nutrition provision and practice and that of consumer preference for nutrition care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a multi-centre observational study of nutrition practices in critically ill adults across ANZ. Two study periods are proposed, the first confirmed period in Q3-2024 and the second in 2026.

This study is part of a larger study which consists of three interconnected streams. This study forms part of Stream 2 which is about understanding nutrition practice and provision in adults with critical illness. The findings from this study will be used to inform the development and implementation of new models of nutrition care for adults with critical illness.

On the day of study commencement (day 1), all patients treated in the ICU and admitted to the ICU after 00:00 will be screened for eligibility. Observational data will be collected days 1 and 3 of their ICU stay (whilst present in ICU) and then days 7, 14, 21 and 28 (whether they are in ICU or the ward) as well as the first full day on the ward (day after ICU discharge).

At the completion of the project, the investigators will hold the largest sample of nutrition care in critical illness in Australia (approximately 1200 Adult patients including the pilot data period) and the only international database to include the period after ICU discharge. This proposal directly links with the National Safety and Quality Health Service (NSQHS) Standard 5 (Comprehensive Care) and Standard 2 (Partnering with Consumers) and will rapidly provide data about nutrition care and hospital acquired malnutrition (a serious reportable consequence under Standard 5) to inform the accreditation process and provide a risk mitigation strategy to prevent malnutrition before it occurs. This data will be used to improve and re-design nutrition care, as well as generate new research priorities that are highly relevant to issues within clinical care, with the potential to save millions of dollars in healthcare expenditure nationally.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

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

Study Contact

Study Locations

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

In a 7 day study period, all adult patients present in the ICU who meet all of the inclusion criteria and no exclusion criteria will be included.

Description

Inclusion Criteria:

  1. Age 18 years or older
  2. Admitted to ICU after 00:00 on the date of study commencement
  3. Remain in ICU for ≥ 48 hours

Exclusion Criteria:

  1. Patients who have been deemed ready to be discharged by the treating team within 48 hours of ICU admission but have not been able to be discharged within 48 hours of ICU admission for logistical reasons (e.g., due to bed unavailability, inability to return home)
  2. Patients who have been admitted for palliative care or organ donation or made palliative within 48 hours of ICU admission

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
Nutritional outcomes
Time Frame: Up to day 28 of hospitalization
Protein and energy prescription and provision
Up to day 28 of hospitalization
Nutritional outcomes
Time Frame: Up to day 28 of hospitalization
Use of Enteral Nutrition (EN)
Up to day 28 of hospitalization
Nutritional outcomes
Time Frame: Up to day 28 of hospitalization
Parenteral Nutrition (PN)
Up to day 28 of hospitalization
Nutritional outcomes
Time Frame: Up to day 28 of hospitalization
Oral intake and oral nutrition supplements
Up to day 28 of hospitalization
Nutrition service delivery in the ICU and ward setting
Time Frame: Up to day 28 of hospitalization
Levels of staffing available and service provision for nutrition care in the ICU and on the ward
Up to day 28 of hospitalization
Descriptions of nutrition prescription, delivery and service variability across ANZ
Time Frame: Up to day 28 of hospitalization
Comparison of nutrition care between participating hospitals
Up to day 28 of hospitalization
Patient-centred outcomes
Time Frame: Up to day 28 of hospitalization
Duration of hospital stay
Up to day 28 of hospitalization
Patient-centred outcomes
Time Frame: Up to day 28 of hospitalization
Mortality
Up to day 28 of hospitalization
Patient-centred outcomes
Time Frame: Up to day 28 of hospitalization
Discharge destination
Up to day 28 of hospitalization

Collaborators and Investigators

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

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)

August 26, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ANZIC-RC/ER002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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