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

Renal Insufficiency Clinical Trial

— SYSTOE-HAIDI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04451018
• Other study ID #: 38RC19.285
• Secondary ID: 2019-A02454-53
• Status: Recruiting
• Start date: June 17, 2020
• Est. completion date: June 17, 2025

Study information

• Verified date: December 2020
• Source: University Hospital, Grenoble
• Contact: Sophie BLAISE
• Phone: +33(0)476 76 55 47
• Email: SBlaise[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 17, 2025
• Est. primary completion date: June 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriopathy Upper Limb
• Digital Pressure
• Renal Insufficiency

Intervention

Other:
• evaluation of arterial anomalies in upper limbs
evaluation of arterial anomalies in upper limbs with doppler ultrasound

Locations

Country	Name	City	State
France	Chu Grenoble Alpes	Grenoble Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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