Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001256561
Ethics application status
Approved
Date submitted
21/09/2024
Date registered
14/10/2024
Date last updated
19/10/2024
Date data sharing statement initially provided
14/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Characteristics and outcomes of nonagenarians admitted to ICU
Scientific title
Characteristics and outcomes of nonagenarians admitted to ICU: a single centre observational study
Secondary ID [1] 313024 0
None
Universal Trial Number (UTN)
U1111-1313-5635
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intensive care 335241 0
Mortality 335242 0
Complications 335243 0
Condition category
Condition code
Physical Medicine / Rehabilitation 331795 331795 0 0
Other physical medicine / rehabilitation
Surgery 331796 331796 0 0
Other surgery
Public Health 331797 331797 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
In this study we will be observing the postoperative outcomes in patients aged 90-100 years who have been at admitted to the Intensive Care Unit (ICU) at The Austin Hospital, a university teaching institution in Melbourne, Australia, between 1 Jan 2010 and 31 December 2020.

Only the de-identified hospital medical record of patients who have been admitted to ICU will be reviewed.

The primary aims are to identify the characteristics, outcomes and mortality of nonagenarian whilst admitted to ICUs and throughout their hospital admission. The secondary aims are to explore the indicators of poor outcomes in nonagenarian patients admitted to ICU, including cause of admission, and validated risk scores.
Intervention code [1] 329573 0
Diagnosis / Prognosis
Comparator / control treatment
This study has no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339432 0
The primary outcome is the mortality of nonagenarian whilst admitted to ICU and throughout their hospital admission.
Timepoint [1] 339432 0
This will be calculated retrospectively from the completion of admission to ICU to death or hospital discharge for the index admission only.
Secondary outcome [1] 439968 0
The secondary outcome will be to measure the Australian and New Zealand Risk of Death (ANZROD) risk score.
Timepoint [1] 439968 0
The Australian and New Zealand Risk of Death (ANZROD) score will be calculated when the patient is admitted to ICU.
Secondary outcome [2] 440199 0
Other secondary outcomes will be to measure the Acute Physiology and Chronic Health Evaluation (APACHE) II score.
Timepoint [2] 440199 0
The APACHE II score will be calculated when the patient is admitted to ICU.
Secondary outcome [3] 440456 0
Other secondary outcomes will be to measure the Acute Physiology and Chronic Health Evaluation (APACHE III) score
Timepoint [3] 440456 0
The APACHE III score will be calculated when the patient is admitted to ICU.
Secondary outcome [4] 440457 0
Other secondary outcomes will be to measure the Glascow Coma Scale (GCS) score.
Timepoint [4] 440457 0
The GCS score will be calculated when the patient is admitted to ICU.

Eligibility
Key inclusion criteria
Inclusion criteria will be patients aged >90 years and <100 years who require an admission to the ICU for any indication.
Minimum age
90 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Statistical analysis will be performed using R software 4.3.2 (R Development Core Team, Vienna, Austria, 2023). Data will de-identified and variable names were encrypted. All data will be coded numerically to maintain blinding of the collected variable characteristics for the statistician.

Data will be presented as median (interquartile range, 25%–75%) or the number of cases (percentile) for descriptive statistics. Cox regression survival analysis will be used to investigate the hazard ratios (HR) and their confidence intervals of predefined risk scores and other clinical variables influencing mortality during ICU or hospital stays. Receiver operating characteristic (ROC) curves will be used to assess the discriminatory power of risk scores in predicting survival outcomes of nonagenarians.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/10/2024
Actual
15/10/2024
Date of last participant enrolment
Anticipated
22/10/2024
Actual
17/10/2024
Date of last data collection
Anticipated
24/10/2024
Actual
18/10/2024
Sample size
Target
89
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27137 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 43214 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 317465 0
Government body
Name [1] 317465 0
Austin Health
Country [1] 317465 0
Australia
Primary sponsor type
Government body
Name
Austin Health
Address
Country
Australia
Secondary sponsor category [1] 319872 0
None
Name [1] 319872 0
Address [1] 319872 0
Country [1] 319872 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316179 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 316179 0
Ethics committee country [1] 316179 0
Australia
Date submitted for ethics approval [1] 316179 0
13/09/2024
Approval date [1] 316179 0
15/10/2024
Ethics approval number [1] 316179 0
HREC/112715/Austin-2024

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

Contacts
Principal investigator
Name 137046 0
Prof Laurence Weinberg
Address 137046 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
Country 137046 0
Australia
Phone 137046 0
+61413244770
Fax 137046 0
Email 137046 0
[email protected]
Contact person for public queries
Name 137047 0
Professor Laurence Weinberg
Address 137047 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
Country 137047 0
Australia
Phone 137047 0
+61413244770
Fax 137047 0
Email 137047 0
[email protected]
Contact person for scientific queries
Name 137048 0
Professor Laurence Weinberg
Address 137048 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
Country 137048 0
Australia
Phone 137048 0
+61413244770
Fax 137048 0
Email 137048 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As this is an observational study, patients have not provided consent for their data to be shared.


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.