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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02225938




Registration number
NCT02225938
Ethics application status
Date submitted
6/08/2014
Date registered
26/08/2014
Date last updated
3/10/2023

Titles & IDs
Public title
ICU Recovery in Australian Patients
Scientific title
ICU Recovery: A Multicentre Cohort Study in Critically Ill Patients to Determine Functional Recovery and Quality of Life
Secondary ID [1] 0 0
SGS15-0104
Universal Trial Number (UTN)
Trial acronym
ICU-RECOVERY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intensive Care Unit Syndrome 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Intensive care survivors - Patients surviving an admission to an intensive care unit
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility of telephone interview
Timepoint [1] 0 0
At completion of telephone interview, expected average of 6 months
Secondary outcome [1] 0 0
Health related quality of life
Timepoint [1] 0 0
At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit

Eligibility
Key inclusion criteria
- ICU patients who have been invasively mechanically ventilated for over 24 hours
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients aged less than 18 years old

- A proven or suspected acute primary brain process that is likely to result in global
impairment of conscious level or cognition (e.g. traumatic brain injury, subarachnoid
haemorrhage, stroke or hypoxic brain injury after cardiac arrest)

- Second or subsequent admission to ICU during a single hospital admission

- Death is deemed imminent and inevitable

- Participants who do not speak English

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
262
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [2] 0 0
The Austin Hospital - Heidelberg
Recruitment hospital [3] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
Epworth Hospital - Richmond
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
3144 - Malvern
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3121 - Richmond

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Increasingly patients with critical illness requiring life support in an intensive care unit
are surviving their hospital admission. Currently the investigators do not know what effect
the ICU admission, and the life support, has on their long-term quality of life and whether
they can return to their pre-illness level of function following ICU.

The investigators aim to test telephone follow-up of ICU survivors in assessing function and
quality of life six months after ICU admission. Additionally, the investigators will identify
if there are factors that lead to poor recovery. The investigators hope this can influence
and change current ICU practice to improve recovery and long-term outcomes for patients.

The investigators aim to select a total of 300 patients from ICU, 75 patients from each of
the four ICUs. If they survive to hospital discharge, patients and their relatives will
receive a telephone questionnaire at 6 months after the ICU admission that aims to assess
their long-term outcomes, including physical, cognitive and emotional function, quality of
life, and whether they have been able to return to work following ICU.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02225938
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carol Hodgson, PhD MRes
Address 0 0
ANZIC-RC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT02225938