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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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Scientific title
ICU Recovery: A Multicentre Cohort Study in Critically Ill Patients to Determine Functional Recovery and Quality of Life
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Secondary ID [1]
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SGS15-0104
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Universal Trial Number (UTN)
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Trial acronym
ICU-RECOVERY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Intensive Care Unit Syndrome
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Intensive care survivors - Patients surviving an admission to an intensive care unit
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Feasibility of telephone interview
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Assessment method [1]
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Determine feasibility of using a telephone interview to ascertain the functional recovery and quality of life and critically ill ICU survivors.
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Timepoint [1]
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At completion of telephone interview, expected average of 6 months
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Secondary outcome [1]
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Health related quality of life
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Assessment method [1]
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Health related quality of life (HRQOL) measured with EuroQol five dimensions questionnaire (EQ-5D) before ICU (retrospective survey) and at 6 months (prospective survey)
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Timepoint [1]
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At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit
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Eligibility
Key inclusion criteria
* ICU patients who have been invasively mechanically ventilated for over 24 hours
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2015
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Sample size
Target
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Accrual to date
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Final
262
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Medical Centre - Clayton
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Recruitment hospital [2]
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The Austin Hospital - Heidelberg
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Recruitment hospital [3]
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Cabrini Hospital - Malvern
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Recruitment hospital [4]
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The Alfred Hospital - Melbourne
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Recruitment hospital [5]
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Epworth Hospital - Richmond
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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3084 - Heidelberg
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Recruitment postcode(s) [3]
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3144 - Malvern
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Recruitment postcode(s) [4]
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3004 - Melbourne
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Recruitment postcode(s) [5]
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3121 - Richmond
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Funding & Sponsors
Primary sponsor type
Other
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Name
Australian and New Zealand Intensive Care Research Centre
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Monash University
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT02225938
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Trial related presentations / publications
Hodgson CL, Udy AA, Bailey M, Barrett J, Bellomo R, Bucknall T, Gabbe BJ, Higgins AM, Iwashyna TJ, Hunt-Smith J, Murray LJ, Myles PS, Ponsford J, Pilcher D, Walker C, Young M, Cooper DJ. The impact of disability in survivors of critical illness. Intensive Care Med. 2017 Jul;43(7):992-1001. doi: 10.1007/s00134-017-4830-0. Epub 2017 May 22. Erratum In: Intensive Care Med. 2017 Dec;43(12):1938. doi: 10.1007/s00134-017-4937-3.
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Public notes
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Contacts
Principal investigator
Name
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Carol Hodgson, PhD MRes
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Address
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ANZIC-RC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Fax
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Email
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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 not provided in
https://clinicaltrials.gov/study/NCT02225938
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