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ISRCTN
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ISRCTN69115386
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DOI
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10.1186/ISRCTN69115386
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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To determine whether repair of asymptomatic stenosis in arteriovenous fistula for hemodialysis can improve vascular access survival
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Scientific title
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To determine whether repair of asymptomatic stenosis in arteriovenous fistula for hemodialysis can improve vascular access survival: an open randomized comparative interventional trial
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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We tested the hypothesis of whether elective repair of subclinical stenosis (i.e. in a well-functioning access capable of delivering adequate dialysis dose) in AVFs with a Qa>500 ml/min could decrease the risk of access failure (the composite of thrombosis and signs of impending thrombosis), improve access use-life, and be cost-effective by comparison with correcting stenosis only when it becomes hemodynamically significant due to the onset of dysfunction detected during dialysis, an otherwise explained decrease in the dose of dialysis delivered), or a Qa <400-500 ml/min, as recommended by the K/DOQI guidelines.
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Lay summary
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Lay summary under review 1
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Ethics approval
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Ethics Committee for Clinical Trials, University Hospital Integrated Verona [Comitato Etico per la Sperimentazione Clinica, Azienda Ospedaliera Universitaria Integrata Verona], 26.09.2006, ref: Prog. Number 1131
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Study design
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Single-centre open randomized comparative interventional trial
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Countries of recruitment
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Italy
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Disease/condition/study domain
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Asymptomatic AVF stenosis
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Participants - inclusion criteria
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1. Age >18 years old, either sex
2. Hemodialysis patients with arteriovenous mature AVF with angiographically-proven significant (>50% reduction in vessel diameter) asymptomatic stenosis (i.e. in a well-functioning access capable of delivering a spKt/V >1.2 within a 4-hour period and no dialysis-related abnormalities) and a Qa >500 ml/min.
3. Able to provide an informed consent
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Participants - exclusion criteria
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Any endovascular or surgical intervention in the 3 months prior to enrolment
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Anticipated start date
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01/10/2006
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Anticipated end date
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30/09/2013
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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80 subjects, equally distributed between the control and treatment arms.
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Interventions
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In the control group, stenosis will be corrected. in response to access dysfunction or a Qa<400 ml/min.
In the treatment group, stenosis will be corrected electively within 2 weeks of enrolment, and imaging for restenosis (by angiography of duplex ultrasound) and re-stenosis repair during the follow-up are performed in cases of Qa<750 ml/min or a >25% drop in Qa. These Qa criteria were choosen because of their high sensitivity to detect stenosis in AVF in our experience [Tessitore et al. AJKD 2003, 42:331]
In both groups, stenosis will be repaired electively by percutaneous transluminal angioplasty (PTA) or surgery (a more proximal neo-anastomosis or a PTFE interposition graft): the choice of intervention was made case by case at discretion of and depending on the availability of the radiologist and the vascular surgeon with the view to correcting stenosis without any major reduction in the venous capital available for puncture [Tessitore et al CJASN 2006; 1:448].
In both groups, thrombectomy was performed depending on the availability of the attending radiologist and vascular surgeon by manual catheter-directed thrombo-aspiration or surgical revision, with the aim of declotting thrombosed AVF within 48 hour of its detection.
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Primary outcome measure(s)
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1. Access failure, the composite of thrombosis or preemptive intervention triggered by signs of impending thrombosis (a Qa<300 ml/min, access recirculation, or a >60 ml/min drop of the prescribed Qb) Tessitore et al. AJKD 2003, 42:331]
2. Access abandonment, because patency could not be restored after a thrombotic episode (because the access was considered unsalvageable or thrombectomy was unsuccessful), or a patent access was unsuitable for cannulation or unable to sustain adeguate dialysis (i.e. a spKt/V<1.0 within a 4-hour hemodialysis session).
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Secondary outcome measure(s)
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Direct cost of access treatment, including all expenses for surveillance and imaging during the follow-up, elective endovascular and surgical intervention, thrombectomy, placement of a new access or a cuffed and uncuffed temporary central venous catheter, and hospitalization.
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Sources of funding
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Division of Nephrology and Dialysis – Azienda Ospedaliera Universitaria Integrata Verona (Italy)
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Trial website
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Publications
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Contact name
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Dr
Nicola
Tessitore
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Address
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Piazzale LA Scuro 10
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City/town
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Verona
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Zip/Postcode
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37133
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Country
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Italy
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Tel
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+39 0458124652
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Fax
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+39 0458124687
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Email
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nicola.tessitore@ospedaleuniverona.it
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Sponsor
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Division of Pediatric Nephrology and Dialysis Unit (UOC Nefrologia e Dialisi dU) (Italy)
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Address
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Piazzale Stefani 1
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City/town
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Verona
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Zip/Postcode
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37126
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Country
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Italy
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Tel
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+39 045 8122528
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Fax
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+39 045 8027311
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Email
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direzionenefrovr@virgilio.it
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Date applied
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14/01/2013
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Last edited
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31/01/2013
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Date ISRCTN assigned
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31/01/2013
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