Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000207415
Ethics application status
Approved
Date submitted
15/03/2007
Date registered
13/04/2007
Date last updated
13/04/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Transthoracic Echocardiography and Transurethral Resection of the
Prostate
Scientific title
High dose versus low dose fluid preloading and the effect on left ventricular volume and function prior to the administration of spinal anaesthesia in patients undergoing transurethral resection of the prostate.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Left ventricular volume and left ventricular function in patients undergoing transurethral resection of the prostate. 1732 0
Condition category
Condition code
Anaesthesiology 1823 1823 0 0
Other anaesthesiology
Surgery 1824 1824 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients receive 5 ml/kg of 0.9% sodium chloride as a standard fluid loading regime.
The intervention group receives a further 10 ml/kg of 0.9% sodium chloride intravenously.

The intravenous fluid is administered until each patient has reached the specific amount calculated by thier weight. The spinal anaesthesia is performed once the fluid loading and the transthoracic echocardiography has been completed.
Intervention code [1] 1650 0
Treatment: Other
Comparator / control treatment
All patients receive 5 ml/kg of 0.9% sodium chloride as a standard fluid loading regime. The control group receives no extra fluids.
Control group
Active

Outcomes
Primary outcome [1] 2557 0
Left ventricular volume and function is assesed by transthoracic echocardiography.
Timepoint [1] 2557 0
At baseline, immediately post intravenous fluid loading, 20 minutes post spinal anaesthesia and 30 minutes post surgery.
Secondary outcome [1] 4402 0
Amount and type of vasopressor administered.
Timepoint [1] 4402 0
The time from the start to the end of the surgery.
Secondary outcome [2] 4403 0
Amount and type of intravenous fluid administered that is separate from the intervention and is dependant on the individual's need during the operation.
Timepoint [2] 4403 0
The time from the start to the end of the surgery.

Eligibility
Key inclusion criteria
Patients undergoing elective transurethral resection of the prostate.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with contraindications to spinal anaesthesia. Patients who require invasive cardiac monitoring.

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)
Allocation concealment is achieved by using numbered sealed opaque envelopes which are only opened prior to study protocol commencing.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The blinded personnel are as follows. The anaesthetist administering the anaesthesia to the patient. The anaesthetist or echocardiographer who is preforming the transthoracic echocardiogram. The anaesthetists who are reviewing the echocardiogram, assessing outcomes and analysing results. The unblinded personell are the research nurses who will be administering the treatment.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1975 0
Hospital
Name [1] 1975 0
Department of Anaesthesia St Vincent's Hospital Melbourne
Country [1] 1975 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia St Vincent's Hospital Melbourne
Address
Country
Australia
Secondary sponsor category [1] 1788 0
None
Name [1] 1788 0
Nil
Address [1] 1788 0
Country [1] 1788 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3671 0
St Vincent’s Hospital
Ethics committee address [1] 3671 0
Ethics committee country [1] 3671 0
Australia
Date submitted for ethics approval [1] 3671 0
Approval date [1] 3671 0
18/05/2005
Ethics approval number [1] 3671 0
001/05

Summary
Brief summary
The primary purpose of this study is to find out what dose of intravenous fluid maintains enough fluid volume in the body after a spinal anaesthetic. Particpiants in this study are randomly assigned to have a high dose of intravenous fluid or a low dose of intravenous fluid. We find out how much fluid is in the body by doing an ultrasound of the heart before the the intravenous fluid is given, after the intravenous fluid is given, after the spinal anaesthetic is given and at the end of the operation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27584 0
Address 27584 0
Country 27584 0
Phone 27584 0
Fax 27584 0
Email 27584 0
Contact person for public queries
Name 10839 0
Simone Said
Address 10839 0
Department of Anaesthesia
St Vincent's Hospital Melbourne
PO Box 2900
Fitzroy VIC 3065
Country 10839 0
Australia
Phone 10839 0
+61 3 92884245
Fax 10839 0
Email 10839 0
[email protected]
Contact person for scientific queries
Name 1767 0
Dr Des McGlade
Address 1767 0
St Vincent's Hospital Melbourne
PO Box 2900
Fitzroy VIC 3065
Country 1767 0
Australia
Phone 1767 0
+61 3 92881011
Fax 1767 0
Email 1767 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.