Blood vessel diameter Blood vessel size
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who are scheduled for creation of an AVF for maintenance haemodialysis. 2. Male or female * 18 years old. 3. Patients are able and willing to give written informed consent. 4. Patients are able to attend once weekly physiotherapy classes. 5. Patients have a cephalic vein diameter equalling at least 1mm.
Exclusion criteria
Exclusion criteria: 1. Any concurrent illness, disability or clinically significant abnormality that may, as judged by the investigator, affect the interpretation of clinical efficacy or safety data or prevent the subject from safely completing the assessments required by the protocol. 2. Current participation in another interventional clinical trial 3. Previous AVF in the ipsilateral arm 4. Patients who are unlikely to adequately comply with the trial*s procedures (due for instance to medical conditions likely to require an extended interruption or discontinuation, history of substance abuse or noncompliance). 5. Patients with absent cephalic vein in the ipsilateral arm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Per-patient change in cephalic vein or radial artery diameter after six weeks of forearm exercise, as assessed by duplex ultrasound at pre-specified locations in the forearm. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in operative plan i.e. when the initial plan of brachiocephalic fistula creation is changed into radiocephalic fistula creation following six weeks of forearm exercise. Minimal cephalic vein diameter at the wrist must be 2.0mm in order to proceed for a radiocephalic fistula. - Cephalic vein diameter end flow six weeks after the operation, as assessed by duplex ultrasound. - Per-patient change of cephalic or basilic vein diameter from the operation until six weeks postoperatively. - If applicable, shunt flow 6 and 12 weeks postoperatively | — |
Countries
Netherlands