Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000393550
Ethics application status
Approved
Date submitted
14/04/2015
Date registered
28/04/2015
Date last updated
10/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study on the influence of anaesthetic choice on prospective outcomes after the creation of an arteriovenous fistula.
Scientific title
Pilot observational study of the influence of anaesthetic choice on arteriovenous fistula failure rate, new peripheral neural symptoms and other comorbidities after the creation of an arteriovenous fistula in patients with end stage renal failure.
Secondary ID [1] 286529 0
nil / none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage renal failure 294749 0
Arteriovenous fistula patency 294750 0
Anaesthesia morbidity 294751 0
Condition category
Condition code
Anaesthesiology 295034 295034 0 0
Anaesthetics
Renal and Urogenital 295035 295035 0 0
Kidney disease
Surgery 295101 295101 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Regional anaesthesia technique that is appropriate for the creation of arteriovenous fistula. (Regional anaesthetic technique involves the administration of any local anaesthetic agent to the upper limb brachial plexus for the purpose of anaesthetising the brachial plexus. These blocks include interscalene, supraclavicular, infraclavicullar, axillary blocks or any combination of the above.) The decision to administer a regional anaesthetic is at the discretion of the anaesthetist and surgeon involved. This study is observational only and will not be altering established practice.
The surgery itself is expected to take between 30 and 90 minutes. Patients will be followed up prospectively for 6 weeks from the time of surgery.
Intervention code [1] 291618 0
Not applicable
Comparator / control treatment
General anaesthesia technique for the creation of arteriovenous fistula. This involves the administration of agents to induce unconsciousness and prevent movement during the operation. For the purposes of this study, the use of a supraglottic or infraglottic airway device defines that general anaesthesia has taken place.
Patients will be followed up prospectively for 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 294796 0
As this is a pilot study with the aim of moving towards a randomised control trial, the primary aim is to obtain a target recruitment rate at each hospital. That is, how many patients are eligible for inclusion in a future randomised trial, based on our inclusion criteria. As this trial is observational, there is no requirement for patients to consent to participate in this study.
Timepoint [1] 294796 0
2 years from start of recruitment, with a minimum timeframe of 1 year from start of recruitment to be able to establish this data (i.e. annual target recruitment rate).
Primary outcome [2] 294797 0
Another important primary outcome for this pilot study is to assess the ability of a new online data collection tool to capture all relevant data. Data has to be entered by research personnel at each hospital which can be performed either after the six-week period of observation or contemporaneously. Thus, another of our primary outcomes is to determine the completion rate of our online data collection tool. The software used will allow for the assessment of completeness of the data collection at each hospital which will be expressed as a percentage.
Timepoint [2] 294797 0
2 years from start of recruitment, with a minimum timeframe of 1 year from start of recruitment to be able to establish this data.
Secondary outcome [1] 314062 0
Incidence of arteriovenous fistula failure at six weeks, as determined by the medical records. This is defined as abandonment or intervention within 6 weeks of initial creation. This outcome is necessary for appropriate planning for a future randomised control trial where this will be the primary outcome.
Timepoint [1] 314062 0
Six weeks from start of surgery.
Secondary outcome [2] 314063 0
Incidence of peripheral neural symptoms (sensory or motor) at six weeks as determined by the medical records. This is necessary for appropriate planning for a future randomised control trial where this is anticipated to be an important secondary outcome.
Timepoint [2] 314063 0
Six weeks from start of surgery.
Secondary outcome [3] 314064 0
The relative risk of arteriovenous failure at six weeks (from medical records) after general anaesthesia compared to regional anaesthesia.
Timepoint [3] 314064 0
Six weeks from surgery.
Secondary outcome [4] 314241 0
The relative risk of peripheral neural symptoms at six weeks (from medical records) after general anaesthesia compared to regional anaesthesia.
Timepoint [4] 314241 0
Six weeks from time of surgery
Secondary outcome [5] 314250 0
The relative risk of inpatient central neurological complications (acute confusional state requiring intervention; neurological deficit consistent with cerebrovascular territory deficit by routine clinical or imaging criteria; all based on medical records) after general anaesthesia compared to regional anaesthesia.
Timepoint [5] 314250 0
From time of surgery to hospital discharge.
Secondary outcome [6] 314251 0
The relative risk of inpatient cardiac complications (new arrhythmia on ECG; acute coronary syndrome by clinical /ECG/ biochemical /pathological evidence; acute pulmonary oedema by clinical /radiological criteria; all based on medical records) after general anaesthesia compared to regional anaesthesia.
Timepoint [6] 314251 0
From time of surgery to hospital discharge.
Secondary outcome [7] 314252 0
The relative risk of inpatient respiratory complications (respiratory distress requiring intervention; new onset hypoxia (SaO2<90%), bronchospasm; aspiration by standard clinical / imaging criteria; pneumothorax by clinical / imaging criteria; all based on medical records) after general anaesthesia compared to regional anaesthesia.
Timepoint [7] 314252 0
From time of surgery until hospital discharge
Secondary outcome [8] 314253 0
The relative risk of other inpatient complications generally attributable to regional anaesthesia not elsewhere mentioned (e.g. wrong limb block; haematoma from local anaesthetic puncture; systemic toxicity; all based on medical records) after general anaesthesia compared to regional anaesthesia
Timepoint [8] 314253 0
From time of surgery until hospital discharge
Secondary outcome [9] 314254 0
The relative risk of other inpatient complications generally attributable to general anaesthesia not elsewhere mentioned (e.g. dental damage, can't intubate / can't oxygenate; all based on medical records) after general anaesthesia compared to regional anaesthesia.
Timepoint [9] 314254 0
From time of surgery until hospital discharge.
Secondary outcome [10] 314255 0
The relative risk of death after general anaesthesia compared to regional anaesthesia; based on medical records
Timepoint [10] 314255 0
Six weeks from time of surgery

Eligibility
Key inclusion criteria
End stage renal failure scheduled for a new creation of an arteriovenous fistula in the upper limb, having a regional or general anaesthetic technique.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women, concurrent surgery on other parts of the body.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The primary outcomes will be described as a proportion with 95% confidence intervals or mean +/- 95% SEM.
Secondary outcomes will also be described by a proportion with 95% confidence intervals.
To determine the impact of anaesthetic technique on postoperative outcomes, univariate analysis will be performed using exact conditional analysis of frequency tables (Chi-squared or Fisher's exact test). Relative risk with confidence intervals will also be produced.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/05/2015
Actual
20/05/2015
Date of last participant enrolment
Anticipated
30/06/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3697 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 3698 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 3699 0
The Northern Hospital - Epping
Recruitment hospital [4] 3700 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [5] 7653 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [6] 7654 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [7] 7655 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment hospital [8] 7656 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment postcode(s) [1] 9529 0
3084 - Heidelberg
Recruitment postcode(s) [2] 9530 0
3128 - Box Hill
Recruitment postcode(s) [3] 9531 0
3076 - Epping
Recruitment postcode(s) [4] 9532 0
3220 - Geelong
Recruitment postcode(s) [5] 15566 0
3050 - Parkville
Recruitment postcode(s) [6] 15567 0
3065 - Fitzroy
Recruitment postcode(s) [7] 15568 0
3350 - Ballarat Central
Recruitment postcode(s) [8] 15569 0
3550 - Bendigo

Funding & Sponsors
Funding source category [1] 291096 0
Other
Name [1] 291096 0
Australian and New Zealand College of Anaesthetists
Country [1] 291096 0
Australia
Primary sponsor type
Individual
Name
Raymond Hu
Address
Department of Anaesthesia
Austin Hospital
145 Studley Road
PO Box 5555
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 289773 0
Hospital
Name [1] 289773 0
Austin Hospital
Address [1] 289773 0
145 Studley Road
PO Box 5555
Heidelberg
Victoria 3084
Country [1] 289773 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292678 0
Austin HREC
Ethics committee address [1] 292678 0
145 Studley Road
PO Box 5555
Heidelberg
Victoria 3084
Ethics committee country [1] 292678 0
Australia
Date submitted for ethics approval [1] 292678 0
Approval date [1] 292678 0
11/09/2014
Ethics approval number [1] 292678 0
HREC/14/Austin352

Summary
Brief summary
Kidney disease is a significant health issue, with around 2500 new patients requiring treatment every year (Australian data). Around half of these patients will need a surgical connection between their artery and vein (an “arteriovenous fistula” or “AVF”) to facilitate being connected to a machine that functions like a kidney (a haemodialysis machine). There are many methods of providing anaesthesia for the creation of an AVF including a local anaesthetic-based technique to numb the entire limb where the AVF will be created, or a general anaesthesia-based technique where consciousness is lost. It is currently not known whether any particular anaesthetic technique is superior. Theoretical advantages of a local anaesthetic-based technique (also known as a “regional anaesthetic”) include the avoidance of a low blood pressure and better surgical conditions by making the artery and vein larger which may prolong the life of the fistula. On the other hand, potential disadvantages of a regional anaesthetic include the risk of nerve injury. There have been no good quality studies evaluating both these issues, although smaller studies have suggested benefit of a regional anaesthetic technique.

The aim of this study is to obtain prospective data from four hospitals regarding the six-week outcomes for patients having their first AVF created under a regional anaesthetic or a general anaesthetic. Patients will be recruited over two years. All four hospitals perform a significant number of regional anaesthetics for this procedure. The main purpose of this study is to determine the number of patients that would be eligible for a future comparative looking at the outcomes of AVF failure and peripheral neural injury; and to determine whether there are appropriate infrastructure mechanisms to collect relevant data for a future comparative trial. Another purpose of this study is to determine the direction of benefit (if any) of using a regional anaesthetic technique over a general anaesthetic technique for this surgery. This data will allow us to assess the feasibility of implementing a future trial where patients will be randomly allocated to receive either a regional anaesthetic or a general anaesthetic for this operation.

Determining the impact of anaesthetic technique on six-week outcomes is important as it has the potential to change anaesthetic practice significantly. Reducing the overall complication rate is beneficial to patients with end stage kidney disease. This will facilitate a smooth transition into haemodialysis after initial AVF creation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56486 0
Dr Raymond Hu
Address 56486 0
Department of Anaesthesia
Austin Hospital
145 Studley Road
PO Box 5555
Heidelberg
Victoria 3084
Country 56486 0
Australia
Phone 56486 0
+61 3 9496 3800
Fax 56486 0
Email 56486 0
[email protected]
Contact person for public queries
Name 56487 0
Dr Raymond Hu
Address 56487 0
Department of Anaesthesia
Austin Hospital
145 Studley Road
PO Box 5555
Heidelberg
Victoria 3084
Country 56487 0
Australia
Phone 56487 0
+61 3 9496 3800
Fax 56487 0
Email 56487 0
[email protected]
Contact person for scientific queries
Name 56488 0
Dr Raymond Hu
Address 56488 0
Department of Anaesthesia
Austin Hospital
145 Studley Road
PO Box 5555
Heidelberg
Victoria 3084
Country 56488 0
Australia
Phone 56488 0
+61 3 9496 3800
Fax 56488 0
Email 56488 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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