Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000518460
Ethics application status
Approved
Date submitted
9/05/2025
Date registered
23/05/2025
Date last updated
23/05/2025
Date data sharing statement initially provided
23/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Mobilisation and vasoactive infusions: An observational study of practice across critical care
Scientific title
Mobilisation and vasoactive infusions: An observational study of practice across critical care
Secondary ID [1] 314416 0
None
Universal Trial Number (UTN)
U1111-1322-5245
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular conditions requiring vasoactive or inotropic support 337435 0
hypotension requiring vasoactive or inotropic support 337432 0
Condition category
Condition code
Cardiovascular 333873 333873 0 0
Other cardiovascular diseases
Physical Medicine / Rehabilitation 333808 333808 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This prospective, single centre observational study will be undertaken for all patients admitted to the ICU and Acute Coronary Care Unit (ACCU) at Canberra Hospital over a three-month period requiring vasoactive and/or inotropic infusions (noradrenalin, adrenalin, dobutamine, vasopressin, milrinone, metaraminol, levasemendin, isoprenaline). This study will measure:
-mobility rates
-dosage of drug administer prior, during and post mobilisation
-level of mobilisation utilising ICU mobility scale
-attachments and sedation medication dosages during mobilisation
-SOFA score on day of mobilisation and 24 hours post
-mobility rates
-adverse events during mobilisation and 24 hours post
-functional outcome at ICU discharge (Acute Care Index of Function).
Observation measures will be taken for the highest level of mobility that day on infusions.
Mobility will be defined as any attempt at out of bed mobility (sitting on the edge of the bed, standing, transferring, ambulating, passively transferred to chair). We propose an observational study as mobilisation of patients on vasoactive and inotropic agents is already considered routine practice by physiotherapists and nursing staff in these areas.
Intervention code [1] 331021 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341402 0
Adverse events associated with mobilisation with vasoactive and/or inotropic support
Timepoint [1] 341402 0
1. During or immediately post mobilisation 2. 24 hours post mobilisation This will be collected from the digital health record
Secondary outcome [1] 447396 0
Functional outcome on ICU discharge
Timepoint [1] 447396 0
On ICU/ACCU discharge
Secondary outcome [2] 447397 0
Intensity of mobilisation on vasoactive and/or inotropic support
Timepoint [2] 447397 0
During mobilisation

Eligibility
Key inclusion criteria
All patients admitted to ICU/ACCU at Canberra Hospital requiring vasoactive and inotropic infusions during the study timeframe
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• <16 years old
• Admitted to ICU for end-of-life care
• Medical conditions requiring prescribed bed rest by a medical officer (e.g. spinal precautions, post operative orders)

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be analysed with R software package. Pearson Chi-Square tests will be used and presented as counts and percentages. For data
analysis of continuous variables, the normal distribution of data will be determined via analysis
for skewness and kurtosis and Shapiro-Wilk’s tests applied. Normally distributed data will be
analysed using independent or paired sample t-tests and reported as mean (± standard
deviation [SD]). Linear regression models will be used to determine any relationship between mobilisation rates and functional outcomes. Logistic regression models will be used to calculate risk ratios for mobilisation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/05/2025
Actual
Date of last participant enrolment
Anticipated
12/08/2025
Actual
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 27918 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 44112 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 318944 0
Government body
Name [1] 318944 0
ACT Health
Country [1] 318944 0
Australia
Primary sponsor type
Hospital
Name
The Canberra Hospital
Address
Country
Australia
Secondary sponsor category [1] 321409 0
None
Name [1] 321409 0
Address [1] 321409 0
Country [1] 321409 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317550 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 317550 0
Ethics committee country [1] 317550 0
Australia
Date submitted for ethics approval [1] 317550 0
11/04/2025
Approval date [1] 317550 0
06/05/2025
Ethics approval number [1] 317550 0
2025.LRE.00095

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

Contacts
Principal investigator
Name 141410 0
Mr Vincenzo Marzano
Address 141410 0
Physiotherapy Department, Building 15, Canberra Hospital, Hospital Road, Garran ACT 2605
Country 141410 0
Australia
Phone 141410 0
+61 410658181
Fax 141410 0
Email 141410 0
[email protected]
Contact person for public queries
Name 141411 0
Vincenzo Marzano
Address 141411 0
Physiotherapy Department, Building 15, Canberra Hospital, Hospital Road, Garran ACT 2605
Country 141411 0
Australia
Phone 141411 0
+61 410658181
Fax 141411 0
Email 141411 0
[email protected]
Contact person for scientific queries
Name 141412 0
Vincenzo Marzano
Address 141412 0
Physiotherapy Department, Building 15, Canberra Hospital, Hospital Road, Garran ACT 2605
Country 141412 0
Australia
Phone 141412 0
+61 410658181
Fax 141412 0
Email 141412 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: This would breach the ethical considerations of the research. Given the small jurisdiction, patients could be identified by components of the data presented



What supporting documents are/will be available?



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.