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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02911896




Registration number
NCT02911896
Ethics application status
Date submitted
25/07/2016
Date registered
22/09/2016

Titles & IDs
Public title
Physical Function in Critical Care (PaciFIC)
Scientific title
Physical Function in Critical Care (PaciFIC): An Multi-centre Observational Study
Secondary ID [1] 0 0
2015026
Universal Trial Number (UTN)
Trial acronym
PaciFIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intensive Care (ICU) Myopathy 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Physical Function in Intensive Care Test scored (PFIT-s) and De Morton Mobility Index from ICU awakening to hospital discharge
Timepoint [1] 0 0
Baseline to hospital discharge (up to 3 months)

Eligibility
Key inclusion criteria
* Adults > 18 years of age
* Mechanically ventilated > 48 hours
* Premorbid able to ambulate at least 10m independently prior to ICU admission (+/- gait aid)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Premorbid physical or cognitive impairment which would prevent ability to perform functional measures
* New neurological impairment such as stroke or spinal cord injury
* Trauma or orthopaedic injury requiring period of immobilization or non weight bearing status
* Traumatic brain injury with focal neurology

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2017
Sample size
Target
Accrual to date
Final
151
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
University of South Australia and Flinders Medical Centre - Adelaide
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Brazil
Country [2] 0 0
Singapore
State/province [2] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Melbourne Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Flinders Medical Centre
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
National University Hospital, Singapore
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Escola Superior da Saude, Brazil
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Dr Selina M Parry, PhD
Address 0 0
University of Melbourne
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents



Results not provided in https://clinicaltrials.gov/study/NCT02911896