Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula (MODIFVASC)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status

Enrolling

Conditions

Renal Failure

Treatments

Procedure: Creation of an arteriovenous fistula

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06297343

2023-A02491-44

Details and patient eligibility

About

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.

Full 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.

Enrollment

544 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.