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Trial registered on ANZCTR


Registration number
ACTRN12621001477819
Ethics application status
Approved
Date submitted
1/09/2021
Date registered
28/10/2021
Date last updated
3/11/2022
Date data sharing statement initially provided
28/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fasting and interruption to enteral nutrition delivery in critically ill patients
Scientific title
Fasting and interruption to enteral nutrition delivery in Australian critically ill patients: an observational study
Secondary ID [1] 305102 0
None
Universal Trial Number (UTN)
Trial acronym
NUTRIENT-Fasting
Linked study record
ACTRN12620001025921
This record is a sub-study of NUTRIENT - Nutrition practice in critically ill adults - an observational study.

Health condition
Health condition(s) or problem(s) studied:
Critical illness 323322 0
Condition category
Condition code
Diet and Nutrition 320883 320883 0 0
Other diet and nutrition disorders
Public Health 320884 320884 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Enteral nutrition (EN) is the most preferred and common method of nutrition provision in mechanically ventilated, critically ill patients. However, EN feeding interruptions are common in the Intensive Care Unit (ICU) and can significantly impact EN provision. Contemporary data in Australia is needed to better understand the frequency and most common reasons for EN feeding interruptions and associations with nutrition adequacy.

NUTRIENT-Fasting is an observational study of EN practices in mechanically ventilated, critically ill adults recruited from 35 Australian ICUs through secondary analysis of the NUTRIENT dataset (Nutrition practice in critically ill adults – an observational study (ACTRN12620001025921)). The aim of this study is to report on EN fasting practices and delivery over the first 7 days of ICU admission in mechanically ventilated, critically ill patients.

No additional participants will be enrolled and there will be no active participant involvement. Routinely collected data will be obtained from medical records. This study will access the NUTRIENT dataset, the variables extracted include:
1) Patient level data: patient demographics, duration of EN cessation prior to tracheal extubation, reasons and duration from all EN interruptions, nutrition prescription and delivery.
2) Site level data: ICU sites with and without fasting guidelines prior to extubation, reported duration in hours recommended for EN cessation (where applicable).
3) Outcome data: duration of mechanical ventilation, number of surgeries, duration of ICU and hospital stay.
Intervention code [1] 321494 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328682 0
EN cessation on the day of tracheal extubation (hours) extracted from the NUTRIENT dataset, in which data was collected from medical records.
Timepoint [1] 328682 0
Day of tracheal extubation within the first seven days of ICU admission.
Secondary outcome [1] 399941 0
EN cessation prior to tracheal extubation compared to that reported in site level fasting guidelines extracted from the NUTRIENT dataset, in which data was collected from medical records and case report forms completed by the dietetic deparment.
Timepoint [1] 399941 0
Day of tracheal extubation within the first seven days of ICU admission.
Secondary outcome [2] 399942 0
Reasons reported for EN interruptions (fasting for procedures, feeding intolerance, no EN access, other) extracted from the NUTRIENT dataset, in which data was collected from medical records.
Timepoint [2] 399942 0
Daily cumulative data collected for the first seven days of ICU admission.
Secondary outcome [3] 399943 0
Daily total EN interruption duration (hours) extracted from the NUTRIENT dataset, in which data was collected from medical records.
Timepoint [3] 399943 0
Daily cumulative data collected for the first seven days of ICU admission.
Secondary outcome [4] 399944 0
Energy adequacy, manually calculated from daily EN formula delivered compared to prescribed targers which were extracted from the NUTRIENT dataset, in which data was collected from medical records.
Timepoint [4] 399944 0
Daily for the first seven days of ICU admission.
Secondary outcome [5] 399945 0
Duration of mechanical ventilation extracted from the NUTRIENT dataset, in which data was collected from medical records.
Timepoint [5] 399945 0
Date of commencement of mechanical ventilation to the date of liberation from mechanical ventilation (or day 28 of admission, whichever occurs first).
Secondary outcome [6] 399946 0
ICU length of admission extracted from the NUTRIENT dataset, in which data was collected from medical records.
Timepoint [6] 399946 0
Date of ICU admission to the date of ICU discharge (or day 28 of admission, whichever occurs first).

Eligibility
Key inclusion criteria
We will include recruited patients from NUTRIENT (ACTRN12620001025921) for the first seven days of ICU admission that received:
- EN on any of the seven day study period;
- Invasive mechanical ventilation received during the study period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Received more than four days of Parenteral Nutrition (PN) in the seven day study period

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be used to describe demographic, fasting themes, average energy and protein provision and clinical outcomes. Mean and standard deviation (SD) will be used for normally distributed data and median and interquartile range (IQR) for skewed data. Proportions will be reported as numbers (%).

Group comparisons (fasted vs not fasted) will be performed using Student’s t-test for normally distributed continuous variables and Wilcoxon rank-sum tests for nonparametric data. Chi-square or Fisher’s Exact tests (as appropriate) will be used for comparing proportions. Where applicable, the difference in nutrition adequacy between groups will be analysed. Other differences between groups in secondary outcomes will be explored. Where applicable, longitudinal analysis will be performed using hierarchical mixed modelling with patients nested within sites and both patients and sites treated as random effects. Analyses will be performed using SAS version 9.4 and a two-sided p-value of 0.05 will be used to indicate statistical significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/06/2021
Date of last participant enrolment
Anticipated
Actual
8/10/2021
Date of last data collection
Anticipated
31/12/2021
Actual
28/02/2022
Sample size
Target
100
Accrual to date
Final
134
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 20304 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 35046 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 309496 0
University
Name [1] 309496 0
Monash University
Country [1] 309496 0
Australia
Primary sponsor type
Individual
Name
Dr Emma Ridley
Address
Australia and New Zealand Intensive Care Research Centre (ANZIC RC)
Department of Epidemiology and Preventive Medicine
Monash University
Level 3, 553 St Kilda Road
Melbourne, VIC 3004
Australia
Country
Australia
Secondary sponsor category [1] 310471 0
None
Name [1] 310471 0
Address [1] 310471 0
Country [1] 310471 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309281 0
Alfred Health Hospital Ethics Committee
Ethics committee address [1] 309281 0
Ethics committee country [1] 309281 0
Australia
Date submitted for ethics approval [1] 309281 0
02/06/2021
Approval date [1] 309281 0
16/06/2021
Ethics approval number [1] 309281 0
342/21
Ethics committee name [2] 309282 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 309282 0
Ethics committee country [2] 309282 0
Australia
Date submitted for ethics approval [2] 309282 0
21/06/2021
Approval date [2] 309282 0
21/06/2021
Ethics approval number [2] 309282 0
29605

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113614 0
Dr Emma Ridley
Address 113614 0
Australia and New Zealand Intensive Care Centre (ANZIC RC)
Department of Epidemiology and Preventive Medicine
Monash University
Level 3, 553 St Kilda Road
Melbourne, VIC, 3004
Australia
Country 113614 0
Australia
Phone 113614 0
+61 3 9903 0350
Fax 113614 0
Email 113614 0
emma.ridley@monash.edu
Contact person for public queries
Name 113615 0
Emma Ridley
Address 113615 0
Australia and New Zealand Intensive Care Centre (ANZIC RC)
Department of Epidemiology and Preventive Medicine
Monash University
Level 3, 553 St Kilda Road
Melbourne, VIC, 3004
Australia
Country 113615 0
Australia
Phone 113615 0
+61 3 9903 0350
Fax 113615 0
Email 113615 0
emma.ridley@monash.edu
Contact person for scientific queries
Name 113616 0
Emma Ridley
Address 113616 0
Australia and New Zealand Intensive Care Centre (ANZIC RC)
Department of Epidemiology and Preventive Medicine
Monash University
Level 3, 553 St Kilda Road
Melbourne, VIC, 3004
Australia
Country 113616 0
Australia
Phone 113616 0
+61 3 9903 0350
Fax 113616 0
Email 113616 0
emma.ridley@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be made available via publication or on request in line with the approved ethics application to protect patient anonymity.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.