Maturation and utilization of distal radial-cephalic arteriovenous fistulae for hemodialysis Urological and Genital Diseases
Conditions
Interventions
Patients with terminal renal insufficiency that have been proposed for a creation of a distal arteriovenous fistulae (radiocephalic) in the arm, will be randomized using simple randomization to the cr
Sponsors
Hospital Clínic de Barcelona
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with chronic renal failure stages 5 and 5D (renal failure in the pre-dialysis stage or in a hemodialysis program), candidates according to usual clinical practice for the creation of a radiocephalic (distal) arteriovenous fistula for hemodialysis 2. Adults (18 years or older), who understand the study and agree to participate in it 3. In the arm proposed for the creation of access (after evaluation of both and patient preference): distal cephalic vein after proximal tourniquet between 2 and 6 mm in diameter, patent, without significant stenosis, with continuity through the forearm and good connection with the deep venous system (by perforating elbow, cephalic or proximal basilic vein), less than 6 mm deep (ultrasound examination) 4. Radial artery of the same extremity, between 2 and 6 mm in diameter, with a distal triphasic curve (normal) and good radial pulse, without mural calcification or occlusion 5. Absence of ischemic or calciphylaxis lesions in the same limb 6. Absence of other arteriovenous accesses in the same upper extremity
Exclusion criteria
Exclusion criteria: 1. Patients who do not agree to participate in the study 2. Patients who cannot or do not want to attend control visits 3. Allergy to Nitinol 4. Known presence of central venous stenosis or occlusion (axillary, subclavian veins, innominate trunk, or superior vena cava). In case of high suspicion, a preoperative phlebographic study will be carried out to rule it out, considering high suspicion or risk: or central venous catheter holder for more than one year, or edema of the upper extremities with the previous creation of arteriovenous fistulas in the upper extremities, or abundant prepectoral collateral circulation, or pacemaker carrier on the same axis, or surgery of the upper extremity or history of peripherally inserted central catheters 5. PICC- in the same extremity 6. Less than one year of life expectancy 7. Stenosis >50% in the target veins to be cannulated 8. Previous arteriovenous surgeries in that area or proximal in the same limb. 9. Cardiological criteria for the exclusion of arteriovenous fistulas (heart disease with low ventricular ejection fraction FEV 50 mmHg, distal vasculopathy or unstable ischemic heart disease) 10. Not be a candidate for the creation of distal arteriovenous fistulas (radiocephalic): 10.1. Distal cephalic vein (forearm) or radial artery less than 2 mm in diameter 10.2. Vein without continuity (presence of stenosis or areas less than 2 mm in diameter) or without communication with proximal, superficial or deep veins
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of maturation of radiocephalic arteriovenous fistulas after 1 year of its creation. A fistula is considered mature when is suitable to be punctured for hemodialysis sessions, after a specialized nurse or medical evaluation or ultrasound measurements, following the European Society for Vascular Surgery (ESVS) and Kidney Disease Outcomes Quality Initiative (KDOQUI) guideline definitions | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Primary patency (PP), assisted primary patency (PA) and secondary patency (PS) at 1 year of follow-up 2. The use of these accesses in those patients in the hemodialysis program: 2.1. PP will be considered the patency of the vascular access until its first: open or endovascular procedure to avoid its occlusion; open or endovascular procedure to declot it; definitive thrombosis or occlusion (time from creation to any procedure to prevent thrombosis, treat thrombosis, or definitive thrombosis) 2.2. Assisted PA will be considered the patency of the vascular access until its first: open or endovascular procedure to declot it; definitive thrombosis or occlusion (time from creation to any procedure to treat thrombosis, or definitive thrombosis) 2.3. PS will be considered the patency of the vascular access until its definitive thrombosis or definite (time from creation to definitive thrombosis) | — |
Countries
Spain
Outcome results
None listed