Hand ischaemia risk after creating an arteriovenous fistula

Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula

This study will see how often and why adults with stage 5 chronic kidney disease develop short- or medium-term hand ischaemia after an arteriovenous fistula is created.

Quick facts

• Study type: Observational
• Enrollment: 544 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche (Academic / other)
• Locations: 1 site (Paris)
• Trial ID: NCT06297343 on ClinicalTrials.gov

What this trial studies

This is a prospective, non-interventional, single-centre descriptive study enrolling adult patients with stage 5 chronic kidney disease who are scheduled for an arteriovenous fistula at Hôpital Privé des Peupliers. Routine clinical and vascular function data will be collected before surgery and at 1, 6, and 12 months after the procedure to identify functional vascular changes and clinical factors linked to short- and medium-term hand ischaemia. No experimental treatment, randomisation, or comparator is used and all care follows standard practice. The aim is to characterise the frequency, timing, and predictors of access-related hand ischaemia to inform future risk stratification and management.

Who should consider this trial

Good fit: Adults aged 18 or older with stage 5 chronic kidney disease (on dialysis or not) who are scheduled for an arteriovenous fistula at the study centre and can attend the required follow-up visits and provide informed non-opposition.

Not a fit: Patients with contraindications to the planned surgery, limited life expectancy, concurrent medical or surgical interventions, pregnancy or breastfeeding, inability to attend follow-up visits, or current participation in another clinical trial are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the findings could help clinicians predict which patients are at higher risk of hand ischaemia after fistula creation and improve pre-operative counselling and monitoring.

How similar studies have performed: Other observational studies have described access-related hand ischaemia and some associated risk factors, but prediction remains imperfect and additional single-centre datasets are common.

Eligibility criteria

Inclusion Criteria:

* 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;
* Patient having been informed and having formulated his/her oral non-opposition to participate in the research.

Exclusion Criteria:

* 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;
* Other surgical or medical intervention planned during the study;
* Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
* Participating in another clinical trial, or in a period of exclusion from another clinical trial;
* Patient under guardianship or deprived of liberty.

Where this trial is running

Paris

• Hôpital Privé des Peupliers — Paris, France (Recruiting)

Study contacts

• Study coordinator: Viviane DUEDAL, MD

Conditions Renal Failure