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

NCT06297343 | Recruiting

• 1 other identifier: 2023-A02491-44
• Study Type: observational
• Target: 544
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (1)

• 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)

  12 months

Study Arms (1)

Adult patients with chronic renal failure

Adult patients with chronic renal failure for whom arteriovenous fistula creation is planned

Procedure: Creation of an arteriovenous fistula

Interventions

Creation of an arteriovenous fistula PROCEDURE

Patients 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.

Adult patients with chronic renal failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be adult patients suffering from chronic renal failure for whom the creation of an arteriovenous fistula is planned.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Patient under guardianship or deprived of liberty.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Hôpital Privé des Peupliers

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Viviane DUEDAL, MD

CONTACT

6 70 80 18 98; v.duedal@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 7, 2024
• Study Start: October 20, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

FR (1)