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

NCT04451018 | Unknown

• 2 other identifiers: 38RC19.2852019-A02454-53
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Arteriopathy Upper Limb; Renal Insufficiency; Digital Pressure

Outcome Measures

Primary Outcomes (1)

• arterial condition of the upper limbs

  Description of the arterial condition with duplex ultrasound of the upper arteries: incompressibility or thrombosis of ulnar and/or radial arteries

  24 HOURS

Interventions

evaluation of arterial anomalies in upper limbs OTHER

evaluation of arterial anomalies in upper limbs with doppler ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic renal failure patient with nephrologist's decision to pre-dialysis

You may qualify if:

• 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

You may not qualify if:

• Subject under guardianship or subject deprived of liberty Failure to obtain patient's consent

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Chu Grenoble Alpes

Grenoble, 38043, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Sophie BLAISE

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie BLAISE

CONTACT

+33(0)476 76 55 47; SBlaise@chu-grenoble.fr

Fatima BOUCHAFA

CONTACT

04 76 76 51 49

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: June 30, 2020
• Study Start: June 17, 2020
• Primary Completion: June 17, 2025
• Study Completion: June 17, 2025
• Last Updated: December 23, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)