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The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

Please note that the ANZCTR will be unattended from Friday 18th April until Tuesday 22nd April due to the Easter long weekend. Submissions and updates will not be processed during that time.



Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02841943




Registration number
NCT02841943
Ethics application status
Date submitted
15/07/2016
Date registered
22/07/2016

Titles & IDs
Public title
Fluid Responsiveness After CArdiac Surgery Study
Scientific title
Fluid Responsiveness After Cardiac Surgery (FRACAS) Study
Secondary ID [1] 0 0
LIVICU001
Universal Trial Number (UTN)
Trial acronym
FRACAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically Ill 0 0
Hypovolemia 0 0
Condition category
Condition code
Blood 0 0 0 0
Other blood 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
Fluid bolus responsiveness
Timepoint [1] 0 0
Approximately 30 minutes
Primary outcome [2] 0 0
Volume management responsiveness
Timepoint [2] 0 0
Approximately 6 hours
Secondary outcome [1] 0 0
Morbidity
Timepoint [1] 0 0
At ICU discharge, an average of 4 days
Secondary outcome [2] 0 0
Mortality
Timepoint [2] 0 0
Up to 3 months

Eligibility
Key inclusion criteria
* Admitted following elective cardiac surgery
* Adult (>18 years of age)
* Pulmonary artery, central venous and arterial catheters inserted
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Emergency Patients (surgery immediately or within 12 hours of admission to hospital)
* Children (< 18 years of age)
* Patients admitted to ICU with ongoing extracorporeal circulatory support
* Patients re-admitted to ICU within same index hospital admission

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
1/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
102
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District - Liverpool
Recruitment postcode(s) [1] 0 0
1871 - Liverpool

Funding & Sponsors
Primary sponsor type
Other
Name
South West Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Anders Aneman, MD, PhD
Address 0 0
Liverpool Hospital, South Western Sydney Local Health District
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


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/NCT02841943