Hand ischaemia risk after creating an arteriovenous fistula
Official title: Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula
Run by GCS Ramsay Santé pour l'Enseignement et la Recherche · NCT06297343 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 544 (estimated) |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | October 20, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | November 24, 2025 |
| Trial ID | NCT06297343 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Hôpital Privé des Peupliers
Paris, France Recruiting
Study contacts
- Study coordinator: Viviane DUEDAL, MD
- Email: v.duedal@gmail.com
- Phone: 6 70 80 18 98
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.