Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula (MODIFVASC)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Viviane DUEDAL, MD
- Phone Number: +33 6 70 80 18 98
- Email: v.duedal@gmail.com
Study Locations
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Paris, France, 75013
- Recruiting
- Hopital Prive des Peupliers
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adult patients with chronic renal failure
Adult patients with chronic renal failure for whom arteriovenous fistula creation is planned
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occurrence of ischaemia of the hand
Time Frame: 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
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12 months
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-A02491-44
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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