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Trial registered on ANZCTR


Registration number
ACTRN12620000602921
Ethics application status
Approved
Date submitted
14/05/2020
Date registered
25/05/2020
Date last updated
25/05/2020
Date data sharing statement initially provided
25/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Post-Intensive Care Nutrition Status in Patients with COVID-19
Scientific title
Post-Intensive Care Nutrition Status in Patients with COVID-19
Secondary ID [1] 301163 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID- 19 317300 0
Post-Intensive Care nutrition 317301 0
Condition category
Condition code
Diet and Nutrition 315423 315423 0 0
Other diet and nutrition disorders
Respiratory 315583 315583 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
As an observational study, data will be collected with the aim of quantifying the effect of the COVID-19 respiratory pandemic on nutrition intake, processes and dietetic resourcing in patients admitted to intensive care in Australia that survive to the ward.

Nutrition data will be collected for patients once they are discharged to an acute hospital ward for every 7 days up to hospital discharge or day 28.

Data will be collected retrospectively for patients' ICU admission, including patient demographics and nutrition data. Therefore, data may be collected retrospectively for patients who were admitted and enrolled into the SPRINT-SARI study, the date of which may be prior to this trial registration and study commencement.
Intervention code [1] 317478 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323673 0
Nutrition service delivery assessed from patient medical records e.g. frequency of dietetic review in ICU and post-ICU ward
Timepoint [1] 323673 0
At any time during intensive care admission and acute ward admission, every 7 days for up to 28 days.
Primary outcome [2] 323674 0
Nutrition provision at the patient level assessed from patient medical records. e.g. provision of parenteral nutrition, enteral nutrition, oral intake
Timepoint [2] 323674 0
At any time during intensive care admission and acute ward admission, every 7 days for up to 28 days.
Primary outcome [3] 323675 0
Proportion of patients diagnosed with malnutrition using any of the the validated malnutrition screening and assessment tools, For example malnutrition screening tools:
-Malnutrition Screening Tool (MST),
-Malnutrition Universal Screening Tool (MUST)
-Modified NUTrition Risk In the Critically ill (mNUTRIC)
-Mini Nutritional Assessment (MNA)
-Mini Nutritional Assessment – Short Form (MNA-SF)
-Nutrition Risk Screening (NRS-2002).
For example malnutrition assessment tool:
-Patent Generated Subjective Global Assessment (PG-SGA)
-Subjective Global Assessment (SGA)
-Mini-Nutritional Assessment (MNA)
Timepoint [3] 323675 0
Validated malnutrition screening and assessment tools used at any time during intensive care admission and anytime on the post-ICU acute ward up to 28 days.
Secondary outcome [1] 383110 0
If received enteral nutrition while in the prone position - assessed from patient medical records.

Timepoint [1] 383110 0
At any time during intensive care admission.
Secondary outcome [2] 383231 0
Difficulties with enteral feeding while in the prone position - assessed from patient medical records.
Timepoint [2] 383231 0
At any time during intensive care admission.
Secondary outcome [3] 383232 0
Upper gastric residual volumes used while in the prone position - assessed from patient medical records.
Timepoint [3] 383232 0
At any time during intensive care admission.
Secondary outcome [4] 383233 0
Specific management strategies used during nutrition provision in the prone position - assessed from patient medical records.
Timepoint [4] 383233 0
At any time during intensive care admission.

Eligibility
Key inclusion criteria
Only patients included in Short Period Incidence Study of Severe Acute Respiratory Infection (SPRINT-SARI) ( https://www.anzics.com.au/current-active-endorsed-research/sprint-sari/) will be included in this nutrition study. Patients admitted to the participating sites and enrolled in SPRINT-SARI will be screened at ICU discharge for eligibility for inclusion in the study. All investigators involved in screening and recruitment are employed by the corresponding sites and will have access to identifiable patient information purely for the purpose of study eligibility and study data collection. The SPRINT-SARI patient identification number (PIN) will be recorded as a case report form data point to allow for data linkage at a later date.
SPRINT-SARI will enrol all patients admitted to hospital with suspected or proven acute novel Coronavirus (nCoV) infection as main cause for admission.

The study population for SPRINT-SARI, as follows:
All patients newly admitted to participating hospitals, of any age, presenting with SARI during the study period. Patients will be eligible for the study if the patient meets the case definition for SARI.

A suspected or proven acute respiratory infection requiring new inpatient admission with onset within the past 14 days. With one or more of the inclusion criteria.
Inclusion Criteria:
-A history of feverishness or measured fever of greater than of equal to 38 deg C;
-Cough;
-Dyspnoea (shortness of breath) OR Tachypnoea.

Additional inclusion for this study:
- COVID-19 positive diagnosis
- Admitted to an Intensive Care Unit (ICU)


Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Admitted to an Intensive Care Unit (ICU) for <24 hours
- Not discharged to an acute ward post an ICU admission
- For palliative care on ICU discharge


Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
This study will quantify nutrition intake, resourcing, and clinical outcomes in ICU survivors admitted to ICU during a respiratory pandemic in Australia. The data analysis will be primarily quantitative, with data presented as counts (n) and percentages (%). No sample size calculation has been conducted, and instead all patients admitted that meet inclusion criteria and no exclusion criteria at participating sites will be included.

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,NT,QLD,SA,VIC
Recruitment hospital [1] 16593 0
The Alfred - Melbourne
Recruitment hospital [2] 16594 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 16595 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 16596 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [5] 16671 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [6] 16672 0
Gold Coast University Hospital - Southport
Recruitment hospital [7] 16673 0
Nepean Hospital - Kingswood
Recruitment hospital [8] 16674 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [9] 16675 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment postcode(s) [1] 30183 0
3004 - Melbourne
Recruitment postcode(s) [2] 30184 0
5000 - Adelaide
Recruitment postcode(s) [3] 30185 0
3050 - Parkville
Recruitment postcode(s) [4] 30186 0
2050 - Camperdown
Recruitment postcode(s) [5] 30267 0
4029 - Herston
Recruitment postcode(s) [6] 30268 0
4215 - Southport
Recruitment postcode(s) [7] 30269 0
2747 - Kingswood
Recruitment postcode(s) [8] 30270 0
0810 - Tiwi
Recruitment postcode(s) [9] 30271 0
3550 - Bendigo

Funding & Sponsors
Funding source category [1] 305606 0
Self funded/Unfunded
Name [1] 305606 0
Unfunded
Address [1] 305606 0
This observational study is currently unfunded.
Country [1] 305606 0
Primary sponsor type
Other Collaborative groups
Name
The Australian and New Zealand Intensive Care Research Centre
Address
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine, Monash University
Level 3, 553 St Kilda Road
Melbourne, Victoria, 3004
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 306019 0
None
Name [1] 306019 0
Address [1] 306019 0
Country [1] 306019 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305903 0
Alfred Hospital HREC
Ethics committee address [1] 305903 0
55 Commercial Rd,
Melbourne VIC, 3004
Australia
Ethics committee country [1] 305903 0
Australia
Date submitted for ethics approval [1] 305903 0
24/04/2020
Approval date [1] 305903 0
01/05/2020
Ethics approval number [1] 305903 0
63512 (Local reference: Project 233/20); ANZIC-RC/ER003

Summary
Brief summary
Patients with COVID-19 admitted to intensive care are at high risk of nutritional concerns such as high fevers, increased energy utilisation, impaired glucose utilisation, and increased catabolic state and protein breakdown. Post-ICU there may be significant effects on appetite, taste sensations and direct gastrointestinal affects resulting in diarrhoea, nausea, and vomiting. While no data exist on nutritional intake post-ICU in patients diagnosed with COVID-19, significant nutritional deficits in other cohorts of ICU survivors have been demonstrated. Further, similar conditions, such as Acute Respiratory Distress Syndrome, are associated with substantial acute weight loss during hospitalisation, with long-term muscle weakness and functional impairments. If they survive, patients with COVID-19 are likely to have prolonged recovery and stay in hospital for a significant length of time. Coupled with stretched healthcare resources, this cohort of patients may be particularly susceptible to nutritional deficits, declining nutritional status, and poor functional recovery. Given there is limited available data to guide the optimal nutritional management of patients with COVID-19, we aim to quantify nutrition intake and process in survivors of COVID-19 after ICU discharge.

Therefore, we are conducting a multi-centre observational study, across participating sites in Australia.

As this is a descriptive study the following (but not limited to) outcomes are of interest:
- Nutrition service delivery
- Nutrition provision at the patient level
- Nutrition information on patients with COVID-19
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102002 0
Dr Emma Ridley
Address 102002 0
The Australian and New Zealand Intensive Care Research Centre
School of Public Health and Preventive Medicine, Monash University
Level 3, 553 St Kilda Road
Melbourne, Victoria 3004
AUSTRALIA
Country 102002 0
Australia
Phone 102002 0
+61 3 99030350
Fax 102002 0
Email 102002 0
emma.ridley@monash.edu
Contact person for public queries
Name 102003 0
Dr Emma Ridley
Address 102003 0
The Australian and New Zealand Intensive Care Research Centre
School of Public Health and Preventive Medicine, Monash University
Level 3, 553 St Kilda Road
Melbourne, Victoria 3004
AUSTRALIA
Country 102003 0
Australia
Phone 102003 0
+61 3 99030350
Fax 102003 0
Email 102003 0
emma.ridley@monash.edu
Contact person for scientific queries
Name 102004 0
Dr Emma Ridley
Address 102004 0
The Australian and New Zealand Intensive Care Research Centre
School of Public Health and Preventive Medicine, Monash University
Level 3, 553 St Kilda Road
Melbourne, Victoria 3004
AUSTRALIA
Country 102004 0
Australia
Phone 102004 0
+61 3 99030350
Fax 102004 0
Email 102004 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
No individual participant data will be available as this is an observational study only for the purposes of assessing nutritional intake and processes during the COVID-19 pandemic.
What supporting documents are/will be available?
No other documents available
Summary results
No Results