NCT05082792

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

October 15, 2021

Last Update Submit

October 15, 2021

Conditions

Doppler Ultrasound in Arteriovenous Fistula Preoperative Evaluation and Post-operative Periodic Monitoring

Keywords

hemodialysis in CKD. AVF. CDUS

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Study Arms (1)

doppler US for native AVF in upper limb

OTHER

creation of native arteriovenous fistula in upper limb in chronic kidney disease patients on hemodialysis

Diagnostic Test: doppler ultrasound

Interventions

doppler ultrasoundDIAGNOSTIC_TEST

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

doppler US for native AVF in upper limb

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Egypt

Location

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Interventions

Ultrasonography, Doppler

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor at diagnostic and interventional radiology department Sohag University Hospitals

Study Record Dates

First Submitted

October 15, 2021

First Posted

October 19, 2021

Study Start

October 1, 2021

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

October 19, 2021

Record last verified: 2021-10

Locations

EG(1)