Patients that required the creation of an autogenous elbow arteriovenous fistula (AVF) as permanent access for chronic hemodialysis sessions Not Applicable
Conditions
Interventions
Every 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 bu
Sponsors
Hospital Clinic, University of Barcelona
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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
Exclusion criteria
Exclusion criteria: 1. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maturation 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
| Measure | Time frame |
|---|---|
| Complications, 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) | — |
Countries
Spain
Outcome results
None listed