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

ConditionRenal Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Creation of an arteriovenous fistula

    Procedure/Surgery

    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.

Treatment groups

544 Participants
are divided into 1 treatment group
Group A: Adult patients with chronic renal failure1 intervention

Trial outcomes

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)

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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