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

Renal Failure Clinical Trial

— MODIFVASC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06297343
• Other study ID #: 2023-A02491-44
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: March 2027

Study information

• Verified date: April 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Viviane DUEDAL, MD
• Phone: 6 70 80 18 98
• Email: v.duedal[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 544
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula
• Ischemia
• Renal Failure

Intervention

Procedure:
• Creation of an arteriovenous fistula
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.

Locations

Country	Name	City	State
France	Hôpital Privé des Peupliers	Paris

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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; - cold hand; - pain on exercise and/or during dialysis; - permanent pain, wound (ulceration, necrosis, gangrene)	12 months