Critical IllnessNUTRIENTNCT06576895
Nutrition Practice in Critically Ill Adults
An observational study of Critical Illness, run by Australian and New Zealand Intensive Care Research Centre at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 600 participants
- Where
- 1 siteAustralia
- Study dates
- 26 Aug 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age 18 years or older
- Admitted to ICU after 00:00 on the date of study commencement
- Remain in ICU for ≥ 48 hours
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Monash University
Melbourne, Victoria, 3004
Tina van Tonder, nutrient@monash.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- No intervention
- Keywords
- Intensive Care, Nutrition
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional outcomes
Protein and energy prescription and provision
Measured: Up to day 28 of hospitalization
Nutritional outcomes
Use of Enteral Nutrition (EN)
Measured: Up to day 28 of hospitalization
Nutritional outcomes
Parenteral Nutrition (PN)
Measured: Up to day 28 of hospitalization
Nutritional outcomes
Oral intake and oral nutrition supplements
Measured: Up to day 28 of hospitalization
Nutrition service delivery in the ICU and ward setting
Levels of staffing available and service provision for nutrition care in the ICU and on the ward
Measured: Up to day 28 of hospitalization
Descriptions of nutrition prescription, delivery and service variability across ANZ
Comparison of nutrition care between participating hospitals
Measured: Up to day 28 of hospitalization
Patient-centred outcomes
Duration of hospital stay
Measured: Up to day 28 of hospitalization
Patient-centred outcomes
Mortality
Measured: Up to day 28 of hospitalization
Patient-centred outcomes
Discharge destination
Measured: Up to day 28 of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start26 Aug 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576895
- Sponsor's protocol ID
- ANZIC-RC/ER002
- Acronym
- NUTRIENT
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Practice in Critically Ill Adults - an Observational Study
- ClinicalTrials.gov ID
- NCT06576895
- Acronym / sponsor ID
- NUTRIENT / ANZIC-RC/ER002
- Conditions
- Critical Illness
- Keywords
- Intensive Care, Nutrition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age 18 years or older
- Admitted to ICU after 00:00 on the date of study commencement
- Remain in ICU for ≥ 48 hours
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Nutritional outcomes
Time frame: Up to day 28 of hospitalization
Protein and energy prescription and provision
Nutritional outcomes
Time frame: Up to day 28 of hospitalization
Use of Enteral Nutrition (EN)
Nutritional outcomes
Time frame: Up to day 28 of hospitalization
Parenteral Nutrition (PN)
Nutritional outcomes
Time frame: Up to day 28 of hospitalization
Oral intake and oral nutrition supplements
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
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
Patient-centred outcomes
Time frame: Up to day 28 of hospitalization
Duration of hospital stay
Patient-centred outcomes
Time frame: Up to day 28 of hospitalization
Mortality
Patient-centred outcomes
Time frame: Up to day 28 of hospitalization
Discharge destination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Australian and New Zealand Intensive Care Research Centre at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Ridley, A/Prof (+61 3 9903 0350, nutrient@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional outcomes (time frame: Up to day 28 of hospitalization). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.