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Evaluation of Macro and Microcirculatory Arterial Condition of the Upper Limb in Insufficiently Renal Patients

NCT ID: NCT04451018

Last Updated: 2020-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-17

Study Completion Date

2025-06-17

Brief Summary

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Evaluation of macro and microcirculatory arterial condition of the upper limb in insufficiently renal patients

Hand ischemia affects 1.6 to 8% of patients with arteriovenous fistula (FAV) of hemodialysis in the upper limb. The diagnostic and therapeutic stakes are major as it concerns the functional prognosis of the hand and, to a lesser extent, vascular access for hemodialysis.

In some cases, the diagnosis of ischemic hemo-hijacking is evident, in other cases, the ischemic condition appears to be rather the result of uncompensated arteriatory of the upper limb or limbs. Echo-doppler exploration is usual for assessing vascular access but without validated formal criteria for arterial disease in the upper limbs, with fistula flow calculation and analysis of FAV hemodynamics. Compression manoeuvres on or under the FAV can also be performed. The pressures of the digital arteries are also indicated with non-consensual values found in the literature for the diagnosis of digital ischemia but with varying tools in terms of collection of measurements.

The main objective of this study is to collate the characteristics of arterial condition of the upper limbs of medium or severe renal patients, medium- or short-term candidates for kidney dialysis. The data collected will match the data of the arterial echodoppler as well as measures of pressures doppler laser and plethysmography. Candidates for dialysis tend to be older and polyvascular. A better assessment of the vascular condition of their upper limbs, including the diagnosis of advanced arterial disease, could eventually guide the choice of type of dialysis (compared to an indication of FAV).

Detailed Description

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Prospective, monocentric study

The main objective of the research Description of the arterial condition of the upper limbs of kidney failure patients candidates for dialysis Primary Search Judgment Criterion: Description of the ultrasound characteristics of the arterial echo-doppler of the upper limbs.

Conditions

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Arteriopathy Upper Limb Renal Insufficiency Digital Pressure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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evaluation of arterial anomalies in upper limbs

evaluation of arterial anomalies in upper limbs with doppler ultrasound

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Chronic renal failure patient with nephrologist's decision to pre-dialysis Or Chronic renal insufficient patient with arteriovenous fistula of the upper limb and sign of digital ischemia (cold hand, digital ulcer, digital necrosis) Agreement on the study's non-opposition form Age above or equal 18 years Patient affiliated with a social security plan

Exclusion Criteria

* Subject under guardianship or subject deprived of liberty Failure to obtain patient's consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sophie BLAISE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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Chu Grenoble Alpes

Grenoble, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sophie BLAISE

Role: CONTACT

Phone: +33(0)476 76 55 47

Email: [email protected]

Fatima BOUCHAFA

Role: CONTACT

Phone: 04 76 76 51 49

Facility Contacts

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Sophie G BLAISE

Role: primary

Fatima BOUCHAFA

Role: backup

Other Identifiers

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2019-A02454-53

Identifier Type: OTHER

Identifier Source: secondary_id

38RC19.285

Identifier Type: -

Identifier Source: org_study_id