Role of Color Doppler Ultrasonography in Assessment of Va... | NCT04196478

Studies
Role of Color Doppler Ultrasonography in Assessment of Vascular Access Surveillance in Hemodialysis Patients.

NCT04196478

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Dec 12, 2019Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Arteriovenous Fistula

Interventions

doppler ultrasound

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Estimated

Primary Completion Date

Jan 1, 2021Estimated

Completion Date

Jan 1, 2021Estimated

First Submitted Date

Dec 2, 2019

First Submission Date that Met QC Criteria

Dec 10, 2019

First Posted Date

Dec 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2019

Last Update Posted Date

Dec 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Flow volume.
Outflow vein diameter.
Outflow vein depth.
Resistive index.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
doppler ultrasound	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

adult group

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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)

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001164	Arteriovenous Fistula

Ancestor Terms

ID	Term
D001165	Arteriovenous Malformations
D054079	Vascular Malformations
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018608	Ultrasonography, Doppler

Ancestor Terms

ID	Term
D014463	Ultrasonography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided