Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000091707
Ethics application status
Approved
Date submitted
22/01/2013
Date registered
23/01/2013
Date last updated
14/03/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of focused transthoracic echocardiography on end stage renal failure patients requiring aterio-venous fistula surgery.
Scientific title
The impact of focused transthoracic echocardiography on end stage renal failure patients requiring aterio-venous fistula surgery, in terms of change in Anaesthesia plan
Secondary ID [1] 281820 0
none
Universal Trial Number (UTN)
U1111-1138-7647
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular state 288169 0
renal failure 288170 0
Condition category
Condition code
Cardiovascular 288532 288532 0 0
Diseases of the vasculature and circulation including the lymphatic system
Renal and Urogenital 288539 288539 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The treating anaesthetist will conduct their preoperative clinical assessment and will record their diagnosis and management plans on the research case report forms.
An independent anaesthetist trained in performing TTE (Trans-Thoracic Echocardiography), and not involved directly in patient care, will perform a goal focused TTE (HART scan)
The treating anaesthetist will be shown the forms and findings will be explained to them. The anaesthetist performing the TTE will not provide any opinion on management, but solely describe the findings to the treating anaesthetist
The treating anaesthetist will complete a second management form (which is identical to the pre TTE form).
Any adverse intraoperative events will be recorded (these are defined below)
Postoperative mortality, major adverse cardiac events and NYHA status will be recorded at 1, 6 and 12 months after surgery by patient interview and medical record review. lung scan and record their findings on the case report forms.
The TTE and lung scan will take 15min and be performed once.
Intervention code [1] 286371 0
Not applicable
Comparator / control treatment
No Comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288691 0
Preoperative focused TTE by an independent anaesthetist changes the:
a.     diagnosis of haemodynamically significant cardiovascular disease, haemodynamic state or presence of pulmonary oedema made by the treating anaesthetist >30%
b.     management plan of the treating anaesthetist or surgeon by >30%
compared to prior clinical assessment.
A standardized form will be used and variation from planned anaesthetic will be note post TTE/Lung scan
Timepoint [1] 288691 0
pre-operatively
Secondary outcome [1] 300770 0
Identify the incidence and distribution of clinically significant cardiovascular disease, abnormal haemodynamic state (including pulmonary hypertension, RVSP>60 mm Hg) and pulmonary oedema and pleural effusions.
Timepoint [1] 300770 0
This will be determined by the TTE/Lung scan and the treating anaesthetist informed pre-operatively
Secondary outcome [2] 300771 0
Incidence of vasodilated haemodynamic state and compare to the time interval after last haemodialysis.
Timepoint [2] 300771 0
pre-operatively at the time of the TTE/lung scan

Eligibility
Key inclusion criteria
All patients for Arterio-Venous fistula formation or revision at the Royal Melbourne Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal to participate
Documented TTE within 6 months of Surgery

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2013
Actual
Date of last participant enrolment
Anticipated
1/09/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 456 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 6211 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 286605 0
Hospital
Name [1] 286605 0
Department of Anaesthesia, Royal Melbourne Hospital
Country [1] 286605 0
Australia
Primary sponsor type
Individual
Name
Ruari M Orme
Address
300 Grattan Street, Parkville, Victoria 3050
Country
Australia
Secondary sponsor category [1] 285392 0
None
Name [1] 285392 0
Address [1] 285392 0
Country [1] 285392 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288679 0
Melbourne Health
Ethics committee address [1] 288679 0
300 Grattan Street, Parkville Victoria 3050
Ethics committee country [1] 288679 0
Australia
Date submitted for ethics approval [1] 288679 0
06/11/2012
Approval date [1] 288679 0
Ethics approval number [1] 288679 0
HREC 2012.260

Summary
Brief summary
To assist clinical decision making pre-operatively in renal failure patients having fistula formation, using a trans-thoracic echo, in order to improve patient well-being post-operatively
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37238 0
Dr Ruari M Orme
Address 37238 0
300 Grattan Street, Parkville Vic 3050
Country 37238 0
Australia
Phone 37238 0
+61 3 9342 7000
Fax 37238 0
Email 37238 0
[email protected]
Contact person for public queries
Name 37239 0
Dr Ruari M Orme
Address 37239 0
300 Grattan Street, Parkville, Vic 3050
Country 37239 0
Australia
Phone 37239 0
+61 3 9342 7000
Fax 37239 0
Email 37239 0
[email protected]
Contact person for scientific queries
Name 37240 0
Dr Ruari M Orme
Address 37240 0
300 Grattan Street, Parkville, Vic 3050
Country 37240 0
Australia
Phone 37240 0
+61 3 9342 7000
Fax 37240 0
Email 37240 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.