Comparison of end-to-side vs side-to-side arteriovenous fistula formation in chronic renal failure patients

ISRCTN ISRCTN62033470
DOI https://doi.org/10.1186/ISRCTN62033470
Secondary identifying numbers CEIC_HCB_2016_0495
Submission date
23/08/2016
Registration date
31/08/2016
Last edited
05/09/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Haemodialysis is a procedure that involves diverting blood to a machine to remove waste products and excess fluid. It is used when the kidneys stop working properly. Before haemodialysis can start, patients need to have a special blood vessel created in their arm by connecting an artery to a vein, called an autogenous arteriovenous fistula (AVF). The connection (anastomosis) between the artery and the vein can be performed in a side-to-side or end-to-side fashion. There is a lack of evidence to recommend one anastomosis type over the other. The aim of this study is to find out whether side-to-side AVF anastomosis is better than end-to-side anastomosis at 1 and 6 months follow-up.

Who can participate?
Adult and senior patients (aged over 18) who need an elbow AVF for haemodialysis

What does the study involve?
Every surgeon and centre participating in this study uses their preferred anastomosis type. Including the patient in the study requires close follow-up but no changes in treatment. The following information is collected:
1. Before the operation: participants’ age, sex, other illnesses, previous arteriovenous accesses and central venous lines. A vein and artery ultrasound examination is also carried out.
2. At the time of the operation: the anastomosis type (side-to-side or end-to-side), the vein and artery used, time taken, any other procedures, vein blood flow
3. At 1 month and 6 months follow-up: complications, the status of the AVF, blood flow (ultrasound examination)

What are the possible benefits and risks of participating?
Every surgeon and centre performs their preferred AVF anastomosis, and participating in this study does not change treatment. Participating in this study therefore does not carry any benefits or risks, other than the benefits and risks of AVF creation.

Where is the study run from?
1. Hospital Clínic, Universitat de Barcelona. Barcelona, Spain (lead centre)
2. Hospital Universitari Vall d’Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain
3. Hospital de Mataró. Mataró, Barcelona, Spain
4. Hospital Universitari de Bellvitge, Universitat de Barcelona. l’Hospitalet, Barcelona, Spain
5. Parc de Salut - Hospital del Mar, Universitat Autònoma de Barcelona, Barcelona, Spain
6. Hospital Sant Joan de Déu - Fundació Althaia. Manresa, Barcelona, Spain

When is the study starting and how long is it expected to run for?
September 2016 to March 2018

Who is funding the study?
Hospital Clinic, University of Barcelona (Spain)

Who is the main contact?
Dr Gaspar Mestres
gasparmestres@gmail.com

Contact information

Dr Gaspar Mestres
Scientific

Hospital Clinic, University of Barcelona
C\Villarroel 170
Barcelona
08036
Spain

ORCiD logoORCID ID 0000-0002-8699-7037
Phone +34 (0)932 275 400
Email gasparmestres@gmail.com

Study information

Study designProspective observational study, two arms
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet.
Scientific titleComparison of maturation and functionality of end-to-side vs side-to-side arteriovenous fistula formation as hemodialysis access in chronic renal failure patients
Study objectivesAs compared to end-to-side arteriovenous fistula (AVF) anastomosis, side-to-side anastomosis does not provide benefits in terms of maturation, functionality or complications at one and 6 months follow-up.
Ethics approval(s)Ethics Committee and Investigation Committee, Hospital Clinic and University of Barcelona, 30/06/2016, ref: CEIC_HCB_2016_0495
Health condition(s) or problem(s) studiedPatients that required the creation of an autogenous elbow arteriovenous fistula (AVF) as permanent access for chronic hemodialysis sessions
InterventionEvery surgeon and center participating in this study will perform their preferred anastomosis type (side-to-side vs end-to-side), and including the patient in the study will require close follow-up but no changes in the therapeutic process.

Several data in the preoperative, intraoperative and postoperative period will be recorded:
1. Preoperative: age, sex, comorbidities (diabetes, hypertension, cardiopathy, pneumopathy), previous arteriovenous accesses, previous central venous catheters in the same side. Ultrasound exam (vein and artery patency and diameter)
2. Intraoperative: anastomosis type (side-to-side or end-to-side), vein and artery used, adjunctive procedures, venous outflow, operative time
3. One month follow-up: complications during follow-up, patency, maturation, utility of the AVF, flow (ultrasound)
4. 6 month follow-up: complications during follow-up, patency, maturation, utility of the AVF, flow (ultrasound)
Intervention typeProcedure/Surgery
Primary outcome measureMaturation and utility of the AVF at one and 6 months follow-up:
1. Maturation will be defined, after physical examination by experienced and dedicated staff, as an easily palpable vein, with a straight-superficial segment, length more than 10 cm, sufficient diameter, and good palpable thrill (clinical maturation should assess an AVF that is expected to be suitable for hemodialysis [HD] access and considered appropriate for cannulation with two needles and expected to deliver sufficient blood flow throughout the HD)
2. Functionality: an AVF that is currently being used, successfully, for HD access during HD sessions, delivering the prescribed blood flow without complications
Secondary outcome measuresComplications, secondary interventions and patency (primary, assisted primary and secondary patency) at one and 6 months follow-up.

1. Complications may include:
1.1. AVF thrombosis (occlusion and loss of patency of the AVF)
1.2. AVF-induced ischaemia VA stages 2 to 4 (extremity malperfusion after AVF creation, including stages 2 - loss of sensitivity, pain during HD or exercise, stages 3 - rest pain, stages 4 - digital tissue loss)
1.3. Venous hypertension syndrome: upper arm and hand edema, swelling, cyanosis or ulcers due to increase of venous pressure

2. Secondary interventions: any surgical or endovascular procedure performed over a previous AVF, in order to increase patency, avoid the occlusion of the AVF, to treat stenosis or other problems that may affect AVF utility, or procedures declotting a thrombosed AVF in order to restore patency and utility of this AVF

3. Patency (primary, assisted primary and secondary patency):
3.1. Primary patency: the interval between AVF creation and the first re-intervention (intervention-free access survival) for access dysfunction or thrombosis or the time of measurement of patency
3.2. Assisted primary patency: interval between AVF creation and the first occlusion (thrombosis-free access survival) or measurement of patency including operative/endovascular interventions to maintain the AVF
3.3. Secondary patency: interval between AVF creation and the abandonment of this AVF (i.e. thrombosis) after one or more interventions or achievement of a censored event (death, change of HD modality, loss for follow-up)
Overall study start date15/09/2016
Completion date15/03/2018

Eligibility

Participant type(s)Patient
Age groupMixed
SexBoth
Target number of participants330
Total final enrolment133
Key inclusion criteria1. Adult patients (more than 18 years of age)
2. Underwent new autogenous elbow arteriovenous fístulae as permanent vascular access for hemodialysis in the participating study centers
3. Primary accesses in this location (elbow)
4. In pre-dialysis or already under dialysis treatment
5. Understand this study
6. Able to come to control visits
Key exclusion criteria1. Patients with previous native or prosthetic arteriovenous fistulae in the same elbow or proximally (previous distal wrist fistulas are allowed)
2. Previous history of ipsilateral deep vein thrombosis
3. Patients requiring prosthetic arteriovenous access
4. Patients that do not accept to participate in the study or refuse to come to control visits
Date of first enrolment15/09/2016
Date of final enrolment15/09/2017

Locations

Countries of recruitment

  • Spain

Study participating centres

Hospital Clinic, Universitat de Barcelona
C\ Villarroel 170
Barcelona
08036
Spain
Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona.
Passeig de la Vall d'Hebron, 119-129
Barcelona
08035
Spain
Hospital de Mataró
Carr. de Cirera, 230
Barcelona
08304
Spain
Hospital Universitari de Bellvitge, Universitat de Barcelona
Feixa Llarga, s/n
Barcelona
08907
Spain
Parc de Salut Hospital del Mar
Passeig Marítim, 25-29
Barcelona
08003
Spain
Hospital Sant Joan de Déu. Fundació Althaia
C/ Dr. Joan Soler, s/n
Barcelona
08243
Spain

Sponsor information

Hospital Clinic, University of Barcelona
Hospital/treatment centre

C\Villarroel 170
Barcelona
08036
Spain

ROR logo "ROR" https://ror.org/02a2kzf50

Funders

Funder type

Hospital/treatment centre

Hospital Clinic, University of Barcelona

No information available

Results and Publications

Intention to publish date15/03/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planOnce finished our study, results will be published in a specialized peer-reviewed impact factor journal.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2019 05/09/2019 Yes No

Editorial Notes

05/09/2019: Publication reference and total final enrolment added.