Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06576895




Registration number
NCT06576895
Ethics application status
Date submitted
14/08/2024
Date registered
29/08/2024
Date last updated
29/08/2024

Titles & IDs
Public title
Nutrition Practice in Critically Ill Adults - an Observational Study
Scientific title
Nutrition Practice in Critically Ill Adults - an Observational Study
Secondary ID [1] 0 0
ANZIC-RC/ER002
Universal Trial Number (UTN)
Trial acronym
NUTRIENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No intervention

Other interventions: No intervention
No intervention
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Nutritional outcomes
Timepoint [1] 0 0
Up to day 28 of hospitalization
Primary outcome [2] 0 0
Nutritional outcomes
Timepoint [2] 0 0
Up to day 28 of hospitalization
Primary outcome [3] 0 0
Nutritional outcomes
Timepoint [3] 0 0
Up to day 28 of hospitalization
Primary outcome [4] 0 0
Nutritional outcomes
Timepoint [4] 0 0
Up to day 28 of hospitalization
Primary outcome [5] 0 0
Nutrition service delivery in the ICU and ward setting
Timepoint [5] 0 0
Up to day 28 of hospitalization
Primary outcome [6] 0 0
Descriptions of nutrition prescription, delivery and service variability across ANZ
Timepoint [6] 0 0
Up to day 28 of hospitalization
Primary outcome [7] 0 0
Patient-centred outcomes
Timepoint [7] 0 0
Up to day 28 of hospitalization
Primary outcome [8] 0 0
Patient-centred outcomes
Timepoint [8] 0 0
Up to day 28 of hospitalization
Primary outcome [9] 0 0
Patient-centred outcomes
Timepoint [9] 0 0
Up to day 28 of hospitalization

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
26/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash University - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.

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.
Trial website
https://clinicaltrials.gov/study/NCT06576895
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Emma Ridley, A/Prof
Address 0 0
Country 0 0
Phone 0 0
+61 3 9903 0350
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06576895