Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000070437
Ethics application status
Approved
Date submitted
6/01/2025
Date registered
23/01/2025
Date last updated
23/01/2025
Date data sharing statement initially provided
23/01/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment goals and outcomes in patients greater than 90 years admitted to the intensive care unit
Scientific title
Impact of Treatment Goals on Outcomes in Critically Ill Nonagenarians
Secondary ID [1] 313632 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment limitations 336196 0
Complications 336195 0
Intensive care 336193 0
Mortality 336194 0
Condition category
Condition code
Public Health 332729 332729 0 0
Health service research
Physical Medicine / Rehabilitation 332728 332728 0 0
Other physical medicine / rehabilitation
Surgery 332730 332730 0 0
Other surgery

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 Intensive Care Unit (ICU) across Australia and New Zealand.

The exposure will include nonagenarians having a treatment limitation order (limited treatment) that include patients with a documented treatment limitation, which could involve restrictions on life-sustaining measures based on clinical assessments, prognosis, and patient or family preferences.

Data will be extracted from the Australian and New Zealand Intensive Care Adult Patient Database for patients admitted to the ICU between 2010 and 2023.
Intervention code [1] 330225 0
Diagnosis / Prognosis
Comparator / control treatment
The comparator group will include nonagenarians who receive full active management (full treatment) with no limits on their treatment who receive full ICU interventions aimed at life-sustaining care,

Data will be extracted from the Australian and New Zealand Intensive Care Adult Patient Database for patients admitted to the ICU between 2010 and 2023.
Control group
Historical

Outcomes
Primary outcome [1] 340258 0
The primary outcome will be to evaluate intensive care mortality in nonagenarians admitted to intensive care with treatment limitations and those without treatment limitations. This will be a binary outcome measure of whether patients survive or do not survive their ICU admission.
Timepoint [1] 340258 0
The timepoint will be from admission to ICU to death in ICU.
Primary outcome [2] 340375 0
The second primary outcome will be to evaluate hospital mortality in nonagenarians admitted to intensive care with treatment limitations and those without treatment limitations. This will be a binary outcome measure of whether patients survive or do not survive their hospital admission.
Timepoint [2] 340375 0
The timepoint will from admission to ICU to death in the hospital.
Secondary outcome [1] 443511 0
Secondary outcomes will included both ICU and hospital lengths of stay, measured from ICU or hospital admission to discharge. Predictors of mortality will also be analyzed,
Timepoint [1] 443511 0
This will be calculated retrospectively from the completion of admission to ICU to death or hospital discharge for the index admission only.

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
All statistical analyses will be conducted using R version 4.3.2 (R Foundation for Statistical Computing). Propensity score matching will be performed to balance baseline characteristics between the "full treatment" and "limited treatment" groups, using logistic regression to estimate propensity scores based on age, sex, APACHE III-J score, admission type, and comorbidities.

Matching will be conducted using the MatchIt package (16), employing nearest-neighbor matching with a caliper of 0.1. Covariate balance will be assessed using standardized mean differences (SMDs), with an SMD > 0.1 indicating imbalance. Continuous variables will be summarized as medians (IQR) and will be analyzed using the Wilcoxon rank-sum test, while categorical variables will be analyzed using chi-square or Fisher’s exact tests. Statistical significance will be determined using a p-value threshold of < 0.05, based on null hypothesis significance testing.

ICU and hospital mortality will be evaluated using Kaplan–Meier survival analysis and log-rank tests. Cox proportional hazards models will be used to identify factors associated with mortality. Predictors of mortality will be derived from the multivariate Cox models, which will be systematically developed by including variables with p-values < 0.2 from the univariate analysis, followed by using a stepwise approach to select the best-performing model.

Multicollinearity will be assessed using the variance inflation factor, and proportional hazards (PH) assumptions will be tested using Schoenfeld residuals. Time-dependent hazard ratios will be calculated for variables that violate the PH assumptions. Interaction analyses will be performed to evaluate whether the effect of treatment limitations on mortality differ across subgroups, with interaction terms included in adjusted Cox models.

The results will be presented as hazard ratios (HRs) with 95% confidence intervals.

Differences in ICU and hospital LOS will be assessed using the Wilcoxon rank-sum test. Univariate and multivariate linear regression models will also be systematically developed to further evaluate associations with LOS. Regression results will be reported as ß-coefficients with standard errors (SE), t-values, and p-values.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/05/2024
Date of last participant enrolment
Anticipated
Actual
26/10/2024
Date of last data collection
Anticipated
Actual
7/12/2024
Sample size
Target
37680
Accrual to date
Final
35384
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27450 0
The Alfred - Melbourne
Recruitment hospital [2] 27448 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 43559 0
3084 - Heidelberg
Recruitment postcode(s) [2] 43561 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 318102 0
Government body
Name [1] 318102 0
Austin Health
Country [1] 318102 0
Australia
Primary sponsor type
Government body
Name
Austin Health
Address
Country
Australia
Secondary sponsor category [1] 320461 0
None
Name [1] 320461 0
Address [1] 320461 0
Country [1] 320461 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316748 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316748 0
Ethics committee country [1] 316748 0
Australia
Date submitted for ethics approval [1] 316748 0
15/02/2024
Approval date [1] 316748 0
30/04/2024
Ethics approval number [1] 316748 0
Project No: 253/24

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

Contacts
Principal investigator
Name 138882 0
Prof Laurence Weinberg
Address 138882 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
Country 138882 0
Australia
Phone 138882 0
+61 413244770
Fax 138882 0
Email 138882 0
[email protected]
Contact person for public queries
Name 138883 0
Laurence Weinberg
Address 138883 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
Country 138883 0
Australia
Phone 138883 0
+61 413244770
Fax 138883 0
Email 138883 0
[email protected]
Contact person for scientific queries
Name 138884 0
Laurence Weinberg
Address 138884 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
Country 138884 0
Australia
Phone 138884 0
+61 413244770
Fax 138884 0
Email 138884 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No 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.