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

Not yet recruiting

• Conditions: Renal Failure
• Interventions: Procedure: Creation of an arteriovenous fistula

• Registration Number: NCT06297343
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

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.

Detailed Description

This is a non-interventional, prospective, non-randomised, descriptive, single-centre study with no comparator.

The study population will be adult patients with chronic renal failure for whom an arteriovenous fistula has been planned.

Patients requiring the creation of an arteriovenous fistula by the surgeons at Hôpital Privé des Peupliers will be seen beforehand in the usual pre-operative consultation, during which the surgeon will explain the principle of the operation and the expected benefits/risks. On the day of surgery, patients will undergo the surgical procedure to create an arteriovenous fistula and will be discharged the same day. Patients will be reviewed during post-operative follow-up visits at 1, 6 and 12 months as in standard practice. All the data collected in the study were collected in routine medical practice.

Study Timeline

• Study First Submitted: 2024-02-29
• Study First Submitted QC: 2024-02-29
• Study First Posted: 2024-03-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Study Start: 2025-04
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 544

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult patients with chronic renal failure	Creation of an arteriovenous fistula	Adult patients with chronic renal failure for whom arteriovenous fistula creation is planned

Primary Outcome Measures

Name	Time	Method
Occurrence of ischaemia of the hand	12 months	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)

Trial Locations

Locations (1)

Hôpital Privé des Peupliers; 🇫🇷 Paris, France