The Role of Doppler Ultrasound in Assessment of Local Factors Affecting Maturation of Arteriovenous Fistula in Hemodialysis Patient
Primary Purpose
Doppler Ultrasound in Arteriovenous Fistula Preoperative Evaluation and Post-operative Periodic Monitoring
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
doppler ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Doppler Ultrasound in Arteriovenous Fistula Preoperative Evaluation and Post-operative Periodic Monitoring focused on measuring hemodialysis in CKD. AVF. CDUS
Eligibility Criteria
Inclusion Criteria:
CKD and ESRD patients on hemodialysis, in whom native arteriovenous fistula operation is needed
- both sexes are included.
- age group from 15-80years
- upper limb arteriovenous fistula only.
- native arteriovenous fistula.
- surgically succeeded AVF
Exclusion Criteria:
we will exclude:
- patients refused to be in the research.
- Patients with AVF not in the upper limbs.
- Patient of age less than 15years and above 80years.
- patients with synthetic grafts.
Sites / Locations
- Sohag University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
doppler US for native AVF in upper limb
Arm Description
creation of native arteriovenous fistula in upper limb in chronic kidney disease patients on hemodialysis
Outcomes
Primary Outcome Measures
maturation of AVF
maturation is considered successful if the fistula patent has a diameter >6mm, located <6mm maximum depth from skin surface, with PSV 400cm/s, flow volume 600ml/min, within 6 weeks post-surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05082792
Brief Title
The Role of Doppler Ultrasound in Assessment of Local Factors Affecting Maturation of Arteriovenous Fistula in Hemodialysis Patient
Official Title
The Role of Doppler Ultrasound in Assessment of Local Factors Affecting Maturation of Arteriovenous Fistula in Hemodialysis Patient
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
the long term survival of the chronic kidney disease (CKD) patients depends on the adequacy of dialysis via good vascular access. the arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis. pre-operative evaluation and periodic monitoring of the AVF after creation with well-defined applied criteria by color doppler ultrasound (CDUS) will help to reduce rate of access failure and achieve better cumulative patency rate of fistulas.
Detailed Description
In recent years, the improvement in the diagnosis and treatment of chronic kidney disease (CKD) has led to increase the number of patients who need hemodialysis, adequacy of which depends upon the appropriately placed vascular access. Although the arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis, there is still a high rate of failure to mature in clinical practice. To increase the use of AVFs, especially in the co-morbid patients, a thorough pre-operative evaluation and periodic monitoring after AVF creation by color doppler ultrasound (CDUS) allows placement of AVF in higher proportion of patients, and early detection of access dysfunction with subsequent intervention that reduce the rate of access failure.
Doppler ultrasound is the main imaging modality for assessment of dialysis access circuits as its gives information on the morphological criteria and evaluates the inflow and outflow flows. CDUS is non-invasive modality, of low cost, not using ionizing radiation or iodinated contrast media.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Doppler Ultrasound in Arteriovenous Fistula Preoperative Evaluation and Post-operative Periodic Monitoring
Keywords
hemodialysis in CKD. AVF. CDUS
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
doppler US for native AVF in upper limb
Arm Type
Other
Arm Description
creation of native arteriovenous fistula in upper limb in chronic kidney disease patients on hemodialysis
Intervention Type
Diagnostic Test
Intervention Name(s)
doppler ultrasound
Intervention Description
Doppler ultrasound evaluation of AVF:
pre-operative evaluation: venous system (patency of central veins and deep venous system, patency of superficial veins, the latter diameter, depth form skin surface, distance from nearby artery, any sizable adjacent tributaries), and arterial system including morphological evaluation (course, diameter, wall alterations, any stenoocclusive disorders) and functional evaluation (flow volume and ability to dilate)
post-operative evaluation: anastomotic site (type of anastomosis, patency, diameter, PSV and any other morphologic alterations), inflow afferent artery (diameter, PSV and flow volume), outflow efferent vein (patency, diameter, color flow, spectral waveform)
the first post-operative sonographic evaluation will be done after removal of stiches from the wound and periodic monitoring every one week up until completion of 6 weeks
Primary Outcome Measure Information:
Title
maturation of AVF
Description
maturation is considered successful if the fistula patent has a diameter >6mm, located <6mm maximum depth from skin surface, with PSV 400cm/s, flow volume 600ml/min, within 6 weeks post-surgery
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CKD and ESRD patients on hemodialysis, in whom native arteriovenous fistula operation is needed
both sexes are included.
age group from 15-80years
upper limb arteriovenous fistula only.
native arteriovenous fistula.
surgically succeeded AVF
Exclusion Criteria:
we will exclude:
patients refused to be in the research.
Patients with AVF not in the upper limbs.
Patient of age less than 15years and above 80years.
patients with synthetic grafts.
Facility Information:
Facility Name
Sohag University
City
Sohag
Country
Egypt
12. IPD Sharing Statement
Citations:
Citation
1. Malekmakan L, Haghpanah S, Pakfetrat M et al (2009) Causes of chronic renal failure among Iranian hemodialysis patients. Saudi J Kidney Dis Transpl. 20(3):501-504 2. Shaheen AMFA, Al-Khader A (2005) Epidemiology and causes of end stage renal disease (ESRD). Saudi J Kidney Dis Transplant. 16(3):277-281 3. Malovrh M (2005) Native arteriovenous fistula: preoperative evaluation. Am J Kidney Dis. 39:1218-1225 4. Yerdel MA, Kesenci M, Yazicioglu KM et al (1997) Effect of hemodynamic variables on surgically created arteriovenous fistula flow. Nephrol Dial Transplant. 12(8):1684-1688 5. Wilmink T, Hollingworth L, Powers S et al (2016) Natural history of common autologous arteriovenous fistulae: consequences for planning of dialysis access. Eur J Vasc Endovasc Surg. 51:134-140 6. Lee T (2013) Novel paradigms for dialysis vascular access: downstream vascular biology-is there a final common pathway? Clin J Am Soc Nephrol. 8:2194-2201
Results Reference
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The Role of Doppler Ultrasound in Assessment of Local Factors Affecting Maturation of Arteriovenous Fistula in Hemodialysis Patient
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