About this trial
The purpose of this study is to identify functional vascular changes and clinical factors correlated with the occurrence of short- or medium-term hand ischaemia after arteriovenous fistula creation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years;
Stage 5 chronic kidney disease, on dialysis or not on dialysis;
Requiring the creation of an arteriovenous fistula;
Membership of a social insurance scheme;
Disqualifiers
Contraindication to the proposed surgery ;
Reduced life expectancy in the opinion of the investigator;
Medical or biological conditions which, in the opinion of the investigator, could influence the interpretation of the results of the study or the safety of the patient;
Patient uncooperative with protocol requirements or unable to attend scheduled visits to the centre;
Trial population
The study population will be adult patients suffering from chronic renal failure for whom the creation of an arteriovenous fistula is planned.
Trial design
Cohort
Prospective
Treatments tested in this trial
Creation of an arteriovenous fistula
Procedure/SurgeryPatients will undergo the surgical procedure to create an arteriovenous fistula and will be discharged the same day (outpatient care, or an overnight stay in hospital if they live a long way from the hospital, have multiple pathologies or are socially isolated). An arteriovenous fistula is created under local or general anaesthetic. On the day of the operation, the type of arteriovenous fistula created, the side of the arteriovenous fistula, the location of the arteriovenous fistula and the patency of the arteriovenous fistula will be collected.
Treatment groups
Trial outcomes
Primary outcomes
Occurrence of ischaemia of the hand
Number and proportion of patients with ischaemia (Yes = stages 1, 2 or 3/No = stage 0) according to the preoperative American Vascular Surgery ischaemia classification : 0 - nothing 1. \- cold hand 2. \- pain on exercise and/or during dialysis 3. \- permanent pain, wound (ulceration, necrosis, gangrene)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead sponsor
Euraxi Pharma
Collaborator