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Trial registered on ANZCTR


Registration number
ACTRN12619001769178
Ethics application status
Approved
Date submitted
4/12/2019
Date registered
12/12/2019
Date last updated
12/12/2019
Date data sharing statement initially provided
12/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot and feasibility study investigating the effects of general anaesthesia vs. regional anaesthesia on arteriovenous fistula patency.
Scientific title
General vs. Regional Anaesthesia on arteriovenous Fistula patency (GiRAF): a randomised controlled pilot and feasibility trial
Secondary ID [1] 300004 0
Nil
Universal Trial Number (UTN)
Trial acronym
GiRAF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic kidney disease 315489 0
Surgical Anaesthesia 315490 0
Condition category
Condition code
Renal and Urogenital 313776 313776 0 0
Kidney disease
Anaesthesiology 313777 313777 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brachial plexus block using any established technique e.g. supraclavicular appraoch, infraclavicular approach and axillary approach using ultrasound guidance, according to anaesthetist preference. A minimum of 20 minutes after block completion is required prior to surgery, in order to assess block success.

Local anaesthetic solution for the block will be 1.5% lignocaine + 1 in 200,000 adrenaline together with 1% ropivacaine mixed in a 1:1 ratio.

Minimum volume of local anaesthetic will be 0.3ml/kg if <66kg or 20ml of solution if >66kg. Maximum volume will be 0.3ml/kg if <133kg or 40 ml if >133kg. (This ensures that maximum volumes do not exceed 1.5mg/kg of ropivacaine and 3.5mg/kg of lignocaine.)

Block success will be determined by a documented change in sensation or motor function in the upper limb within 20 minutes of block completion.
Intervention code [1] 316272 0
Treatment: Other
Comparator / control treatment
General anaesthesia using the following drugs delivered intravenously for induction: propofol with supplemental opioids and /or benzodiazepines. Maintenance of anaesthesia can be with either propofol infusion via intravenous route or volatile agents delivered through the inhaled route. A supraglottic device or an endotracheal tube must be inserted to assist ventilation. These procedures will be performed immediately before surgery and continue throughout surgery.

The decision of which airway device to use will rest with the treating anaesthetist.

If an endotracheal tube is used, any muscle relaxant can be used intravenously to achieve paralysis of the larynx (e.g. suxamethonium, atracurium, cisatracurium, vecuronium, rocuronium.)
Control group
Active

Outcomes
Primary outcome [1] 322189 0
Percentage of eligible patients recruited
This will be determined by a screening log that records the number of eligible patients and the number of patients recruited to determine the percentage of eligible patients recruited (numbers recruited dividied by numbers eligible). Eligibility will be determined by examination of the medical record and consent form and through direct inquiry.
Timepoint [1] 322189 0
At time of booking for surgery.
Primary outcome [2] 322190 0
Percent of secondary outcome data successfully collected.
This will be determined by the number of defined endpoints able to be collected at that time point divided the number of defined endpoints that are planned for collection, determined by a combination of vascular ultrasound results, phone interviews and through the medical record.
Timepoint [2] 322190 0
Assessed in completion at 24 weeks post index surgery (creation of AVF)
Secondary outcome [1] 377622 0
Proportion of patients who achieve arteriovenous fistula maturation as determined by ultrasound: i.e. access vessel internal diameter of >= 5mm AND brachial artery flow of >= 500ml/min.
Timepoint [1] 377622 0
5 weeks (+/- 1 week) post index surgery (creation of AVF)
Secondary outcome [2] 377623 0
Proportion of patients who have primary arteriovenous fistula patency - determined by patient phone interview and confirmed through the medical record.
Timepoint [2] 377623 0
12 and 24 weeks post index surgery (creation of AVF)
Secondary outcome [3] 377624 0
Proportion of patients who have functional primary arteriovenous fistula patency - determined by patient phone interview and confirmed through the medical record.
Timepoint [3] 377624 0
12 and 24 weeks post index surgery (creation of AVF)
Secondary outcome [4] 377625 0
Proportion of patients who have cumulative arteriovenous fistula patency - determined by patient phone interview and confirmed through the medical record.
Timepoint [4] 377625 0
12 and 24 weeks post index surgery (creation of AVF)
Secondary outcome [5] 377629 0
Proportion of patients who have functional cumulative arteriovenous fistula patency - determined by patient phone interview and confirmed through the medical record.
Timepoint [5] 377629 0
12 and 24 weeks post index surgery (creation of AVF).
Secondary outcome [6] 377630 0
Number of interventions / procedures related to vascular access, as determined by patient phone interview and confirmed through the medical record.
Timepoint [6] 377630 0
12 and 24 weeks post index surgery (creation of AVF).
Secondary outcome [7] 377631 0
Proportion of patients with any early adverse events (allergic reaction, hypoxia intraoperatively or in post anaesthesia care unit [i.e. SaO2 <91% on room air, or SaO2 >5% below baseline, or PaO2 / FiO2 ratio <3 (mm/%], myocardial injury [troponin concentration >99th percentile upper reference limit], delirium or confusion, unplanned high dependency or intensive care admission, wrong limb surgery or wrong limb blocked) - determined by the medical record.
Timepoint [7] 377631 0
Within 24 hours of index surgery (creation of AVF)
Secondary outcome [8] 377632 0
Proportion of patients with adverse events (myocardial injury and peripheral neural symptoms).

Myocardial injury will be defined by the presence of any troponin concentration >99th percentile upper reference limit as determined by the medical record.

Peripheral neural symptoms will be defined as any new motor and/or sensory changes as determined by phone interview and/or the medical record.
Timepoint [8] 377632 0
12 and 24 weeks post index surgery (creation of AVF)
Secondary outcome [9] 377926 0
Quality of life as determined by EuroQol 5D5L.
Timepoint [9] 377926 0
12 and 24 weeks post index surgery (creation of AVF)

Eligibility
Key inclusion criteria
Adult patients (>18 years).
Stage 4 or 5 chronic kidney disease (CKD) who are undergoing or planning to undergo haemodialysis (HD) within 12 months.
Planned de novo AVF surgery in an upper limb.
Informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women
Patient refusal or inability to consent.
Clinician (surgeon or anaesthetist) decision not to participate (e.g. lack of experience with brachial plexus block).
Contraindications to brachial plexus block (e.g. infection at site of brachial plexus block, coagulopathy, allergy to any local anaesthetic component).
Use of arteriovenous graft material intended.
Any prior AVF surgery on operative upper limb or revision surgery.
Concurrent surgery on other parts of the body at index procedure.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 304456 0
Hospital
Name [1] 304456 0
Austin Hospital
Address [1] 304456 0
145 Studley Road
Heidelberg
Victoria 3084
Country [1] 304456 0
Australia
Primary sponsor type
Individual
Name
Dr Raymond Hu
Address
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 304730 0
None
Name [1] 304730 0
Address [1] 304730 0
Country [1] 304730 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304891 0
Austin HREC
Ethics committee address [1] 304891 0
Ethics and Research Governance Unit
Level 8, Harold Stokes Building
Austin Health
PO Box 5555
Heidelberg
Victoria
Australia 3084
Ethics committee country [1] 304891 0
Australia
Date submitted for ethics approval [1] 304891 0
Approval date [1] 304891 0
19/02/2019
Ethics approval number [1] 304891 0

Summary
Brief summary
Patients who require the creation of a new arteriovenous fistula for future haemodialysis will be recruited for this study. They will have a 50/50 chance of being assigned to receive either a brachial plexus block or a general anaesthetic technique for this operation. The main aim of this small trial is to determine if it will be feasible to perform a future larger trial comparing the effects of these two techniques on arteriovenous fistula patency. Therefore, the dual key outcomes for this trial are the proportion of eligible patients successfully recruited and the ability to complete the desired data collection for all recruited patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98546 0
Dr Raymod Hu
Address 98546 0
Department of Anaesthesia
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 98546 0
Australia
Phone 98546 0
+61 3 94963800
Fax 98546 0
Email 98546 0
raymond.hu@austin.org.au
Contact person for public queries
Name 98547 0
Dr Raymod Hu
Address 98547 0
Department of Anaesthesia
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 98547 0
Australia
Phone 98547 0
+61 3 94963800
Fax 98547 0
Email 98547 0
raymond.hu@austin.org.au
Contact person for scientific queries
Name 98548 0
Dr Raymod Hu
Address 98548 0
Department of Anaesthesia
Austin Hospital
145 Studley Road
Heidelberg
Victoria 3084
Country 98548 0
Australia
Phone 98548 0
+61 3 94963800
Fax 98548 0
Email 98548 0
raymond.hu@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results