Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000890831
Ethics application status
Approved
Date submitted
17/08/2012
Date registered
21/08/2012
Date last updated
21/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
West Australian Restrictive versus Liberal fluid in patients undergoing Major Elective Surgery
Scientific title
Major Abdominal Surgery Restrictive versus Liberal Fluid Regimes and Length of Stay in patients undergoing major elective abdominal surgery
Secondary ID [1] 281055 0
None
Universal Trial Number (UTN)
Trial acronym
WA-RELIEF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Abdominal Surgery 287200 0
Condition category
Condition code
Anaesthesiology 287529 287529 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomised to receive either a high or low volume perioperative intravenous fluid protocol. The use of goal directed devices will be controlled for in the statistical analysis, but their use is not part of the actual protocol . The Restrictive group will be considered the Control group for the purpose of the study design. The Liberal group will receive 10mls / kg at induction, 8 mls per kg per hour intraoperatively, and then 1.5 mls per kilogram intravenously postoperatively. The intention is to cease all fluids ASAP.
Intervention code [1] 285514 0
Treatment: Other
Comparator / control treatment
There will be no "Control" group per se. For the purpose of the statistical analysis and study design the "Restrictive group" will be considered as the "Control". The Restrictive group will receive 5mls/kg at induction, < 5mls / kg / hour for maintenance and < 1 ml per kg post op.
Control group
Dose comparison

Outcomes
Primary outcome [1] 287770 0
Hospital Length of Stay is the primary outcome and will be prospectively observed from admission to primary discharge. On the last day of hospital admission, research nursing staff following up patients on the ward will indicate Yes or No as to whether the patient is in hospital. The difference in days will then be considered the period of hospitalisation
Timepoint [1] 287770 0
At end of hospital stay
Secondary outcome [1] 298808 0
Perioperative complications- comprising :

Respiratory and infective complications will be assessed and the CDC operational definitions of these complications will be employed
Timepoint [1] 298808 0
At end of hospital stay, at thirty day follow up and at one year.

Eligibility
Key inclusion criteria
Elective Major Abdominal Surgery
At least one night in hospital
High Surgical Risk
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Renal Failure
Coagulopathy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Random number generator will be used to generate sequence, with cluster randomisation per centre. Liberal and Restrictive groups will be allocated in a 1:1 overall ratio . The opaque sealaed envelope technique will be used to Single-blinded
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Clustered per centre
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5596 0
6000

Funding & Sponsors
Funding source category [1] 285839 0
Government body
Name [1] 285839 0
State Health Research Advisory Committee, WA
Country [1] 285839 0
Australia
Primary sponsor type
Government body
Name
Health Department of Western Australia
Address
Department of Health
189 Royal Street
East Perth WA 6004
Australia
Country
Australia
Secondary sponsor category [1] 284661 0
None
Name [1] 284661 0
Address [1] 284661 0
Country [1] 284661 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287860 0
Human Research Ethics Committee -Royal Perth Hospital
Ethics committee address [1] 287860 0
Ethics committee country [1] 287860 0
Australia
Date submitted for ethics approval [1] 287860 0
Approval date [1] 287860 0
01/11/2011
Ethics approval number [1] 287860 0
RA-11/035

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

Contacts
Principal investigator
Name 34594 0
Address 34594 0
Country 34594 0
Phone 34594 0
Fax 34594 0
Email 34594 0
Contact person for public queries
Name 17841 0
Tomas Corcoran
Address 17841 0
Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street
Perth
WA 6000
Country 17841 0
Australia
Phone 17841 0
+61 8 92241038
Fax 17841 0
+61 8 92241111
Email 17841 0
[email protected]
Contact person for scientific queries
Name 8769 0
Tomas Corcoran
Address 8769 0
Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street
Perth
WA 6000
Country 8769 0
Australia
Phone 8769 0
+61 8 92241038
Fax 8769 0
+61 8 92241111
Email 8769 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.