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Trial registered on ANZCTR


Registration number
ACTRN12620000006943
Ethics application status
Approved
Date submitted
6/12/2019
Date registered
8/01/2020
Date last updated
8/01/2020
Date data sharing statement initially provided
8/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Enteral protein delivery in Australia and New Zealand critically ill adults.
Scientific title
A prospective, observational study to assess the dose of enteral protein delivered to critically ill adults as standard practice across intensive care units in Australia and New Zealand.
Secondary ID [1] 300025 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 315406 0
Condition category
Condition code
Diet and Nutrition 313704 313704 0 0
Other diet and nutrition disorders
Public Health 313862 313862 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
Data will be collected for all eligible patients as part of standard clinical practice. Both protein prescription and delivery will be collected while the patient is receiving enteral nutrition (EN), up to 28 days, until the patient is discharged from ICU, or dies. For patients discharged and readmitted to the ICU within 28 days of study enrolment still requiring EN, data pertaining to their initial admission only will be included.

The following information will be collected daily (based on a 24 hour calendar day):
1. Nutrition intake:
· Enteral nutrition prescription: At 08:00 each day, the formula name and daily volume prescribed.
· Total enteral nutrition delivered: Formula name, total volume administered within 24 hour period.
· Additional protein delivered.
i. Enteral nutrition supplements (e.g. Beneprotein)
ii. Parenteral nutrition
2. Feed tolerance:
· Total Gastric Residual Volume (GRV) aspirated in 24 hours
· Total GRV discarded in 24 hours.

Discontinuation of data collection and/or withdrawal:
1. Cessation of EN by the treating clinicians
2. Patient is discharged from the ICU before day 28
3. Oral nutrition is commenced
4. Patient dies prior to day 28
Intervention code [1] 316226 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322156 0
Mean daily protein delivered from enteral nutrition alone (g/kg Ideal Body Weight/day). Assessed from medical records.
Timepoint [1] 322156 0
Up to 28 days of ICU admission from the time of study enrolment.
Secondary outcome [1] 377526 0
Mean daily protein delivered from all sources (Enteral Nutrition, Parenteral Nutrition) (g/kg Ideal Body Weight/day). Assessed from medical records.
Timepoint [1] 377526 0
Up to 28 days of ICU admission from the time of study enrolment.
Secondary outcome [2] 377527 0
Mean daily protein prescription (g/kg Ideal Body Weight/day). Assessed from medical records.
Timepoint [2] 377527 0
Up to 28 days of ICU admission from the time of study enrolment.
Secondary outcome [3] 377528 0
Mean daily volume of EN delivered (ml/day). Assessed from medical records.
Timepoint [3] 377528 0
Up to 28 days of ICU admission from the time of study enrolment.
Secondary outcome [4] 377529 0
Mean daily calorie delivery (kcal/kg Ideal Body Weight/day). Assessed from medical records.
Timepoint [4] 377529 0
Up to 28 days of ICU admission from the time of study enrolment.
Secondary outcome [5] 377530 0
Mean Gastric Residual Volume discarded in 24 hours (ml). Assessed from medical records.
Timepoint [5] 377530 0
Up to 28 days of ICU admission from the time of study enrolment.

Eligibility
Key inclusion criteria
1. Aged 18 years or older.
2. Receiving invasive mechanical ventilation.
3. About to commence enteral nutrition (EN) or EN commenced within the preceding 12 hours.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Expected to be receiving oral nutrition within 24 hours of inclusion.
2. Have received EN or parenteral nutrition (PN) for >12 hours in the ICU admission.
3. Death is deemed to be imminent or inevitable during this admission and either the attending doctor, patient or substitute decision maker is not committed to active treatment
4. The patient has an underlying disease that makes survival to 90 days unlikely
5. The patient has a condition in which the treating clinician believes that administration of a very large or small amount of protein (e.g. large burn injury or urea cycle disorder respectively) is indicated.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The primary aim is to establish the current dose of enteral protein that is delivered as standard practice across intensive care units representing usual clinical care. This is an exploratory study only, to provide a baseline of standard clinical practice in Australia and New Zealand, and hence no formal power calculation is required. Data will be analysed using simple descriptive statistics only. Where appropriate, parametric and nonparametric statistics will be used to make comparisons between subgroups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 15377 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 15378 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 15380 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [4] 15411 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [5] 15412 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 28694 0
3084 - Heidelberg
Recruitment postcode(s) [2] 28695 0
5000 - Adelaide
Recruitment postcode(s) [3] 28697 0
5011 - Woodville
Recruitment postcode(s) [4] 28732 0
3050 - Parkville
Recruitment postcode(s) [5] 28733 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 22167 0
New Zealand
State/province [1] 22167 0
Wellington.

Funding & Sponsors
Funding source category [1] 304423 0
Government body
Name [1] 304423 0
The National Health and Medical Research Council (NHMRC)
Address [1] 304423 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 304423 0
Australia
Primary sponsor type
Hospital
Name
Intensive Care Research, Royal Adelaide Hospital.
Address
Intensive Care Research
Critical Care Services
4G751
Royal Adelaide Hospital
1 Port Road
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 304747 0
None
Name [1] 304747 0
Address [1] 304747 0
Country [1] 304747 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304858 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 304858 0
Central Adelaide Local Health Network
Human Research Ethics Committee
Level 3, Roma Mitchell House
North Terrace, Adelaide SA
Australia 5000
Ethics committee country [1] 304858 0
Australia
Date submitted for ethics approval [1] 304858 0
14/11/2019
Approval date [1] 304858 0
05/12/2019
Ethics approval number [1] 304858 0
CALHN Reference number: 120303

Summary
Brief summary
Patients admitted to ICU often suffer from muscle wasting and ICU acquired weakness associated with complications such as reduced mobilisation, respiratory weakness requiring prolonged ventilatory support, and prolonged ICU and hospital length of stay (LOS). There is renewed interest in provision of more protein, as this may increase muscle synthesis and thus improve functional recovery. While international recommendations encourage providing more protein, this is not yet supported by high quality evidence. Previous data from a randomised controlled trial conducted > 10 years ago, as well as survey data from our region, suggests that usual practice is to deliver much less than that recommended by international guidelines. Our group has planned a trial to answer the question whether greater protein doses can improve survival and patient recovery compared to current practice. However, to ensure the standard care arm constitutes true current practice, we need to first quantify how much protein patients in Australia and New Zealand actually receive. We plan to conduct an observational study evaluating current practice. One hundred and twenty patients will be included consecutively across 6 sites and protein delivery evaluated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98430 0
Dr Tejaswini Arunachala Murthy
Address 98430 0
Intensive Care Unit, Royal Adelaide Hospital
Port Road, Adelaide, 5000, SA

Country 98430 0
Australia
Phone 98430 0
+61 8 7074 1763
Fax 98430 0
Email 98430 0
tejaswini.arunachalamurthy@adelaide.edu.au
Contact person for public queries
Name 98431 0
Dr Lee-anne Chapple
Address 98431 0
Intensive Care Unit, Royal Adelaide Hospital
Port Road, Adelaide, 5000, SA

Country 98431 0
Australia
Phone 98431 0
+61 8 7074 1763
Fax 98431 0
Email 98431 0
lee-anne.chapple@adelaide.edu.au
Contact person for scientific queries
Name 98432 0
Dr Lee-anne Chapple
Address 98432 0
Intensive Care Unit, Royal Adelaide Hospital
Port Road, Adelaide, 5000, SA

Country 98432 0
Australia
Phone 98432 0
+61 8 7074 1763
Fax 98432 0
Email 98432 0
lee-anne.chapple@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This observational study will provide data on protein delivery practices in Australian and New Zealand intensive care units for the sole purpose of advising further study designs on protein delivery and clinical outcomes. Hence, the data will not be provided publicly.
What supporting documents are/will be available?
No other documents available
Summary results
No Results