- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06576895
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
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Emma Ridley, A/Prof
- Phone Number: +61 3 9903 0350
- Email: nutrient@monash.edu
Study Locations
-
-
Victoria
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Melbourne, Victoria, Australia, 3004
- Recruiting
- Monash University
-
Contact:
- Tina van Tonder
- Email: nutrient@monash.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 years or older
- Admitted to ICU after 00:00 on the date of study commencement
- Remain in ICU for ≥ 48 hours
Exclusion Criteria:
- 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)
- Patients who have been admitted for palliative care or organ donation or made palliative within 48 hours of ICU admission
Study Plan
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANZIC-RC/ER002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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