NCT04196478

Brief Summary

The aim of this study is to provide an overview of the possible applications of DUS during the maturation and postoperative follow-up of vascular access, with particular emphasis to establish a relationship between doppler Ultrasound parameters including:

  1. 1.Flow volume.
  2. 2.Outflow vein diameter.
  3. 3.Outflow vein depth.
  4. 4.Resistive index.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

December 2, 2019

Last Update Submit

December 10, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maturation of arteriovenous fistulas

    Assess the role of grey scale and color Doppler US in the early detection of failure in the hemodialysis vascular access. Maturation and monitoring\\ surveillance of arteriovenous fistula.

    6 weeks duration follow up

Interventions

a 7.5 MHz ultrasound (US) linear probe is needed, grey-scale ultrasound and Color Doppler and a minimum display facility of the Doppler velocity spectrum for blood flow calculation are mandatory tools.

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsadult group
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Sample size was calculated using Epi-Info 7 software. According to the results of previous study conducted at renal dialysis unit of Assiut university hospital (7) the most common complication occurred in haemodialysis access (A-V fistula) was infected A-V access (23.8%). Based on this prevalence the minimum required sample size for current study is 84 patients. Following assumptions were used to calculate this sample: Target population size = 120 (as number of new haemodialysis patients is 100-120 each year). N.B: in this study we will include all eligible cases at renal dialysis unit of Assiut university i.e., patients of last year (total coverage sample)

You may qualify if:

  • ESRD patients on dialysis with heamodialysis vascular access with adult age group (18 years and above).

You may not qualify if:

  • Patients with chronically occluded vascular access with failed surgical or interventional attempts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arteriovenous Fistula

Interventions

Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

Arteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lina Mohamed Farid

Study Record Dates

First Submitted

December 2, 2019

First Posted

December 12, 2019

Study Start

January 1, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

December 12, 2019

Record last verified: 2019-12