NCT04736875

Brief Summary

Study of the features of hemodynamic and clinical maturation of the native arteriovenous fistula for hemodialysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2022

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

3.1 years

First QC Date

January 27, 2021

Last Update Submit

March 8, 2022

Conditions

End-stage Renal DiseaseHemodialysis Access FailureVascular Access MaturationNative Arteriovenous Fistula

Keywords

hemodialysisnative arteriovenous fistulamaturationfeeding arteryefferent vein

Outcome Measures

Primary Outcomes (60)

  • Volume flow

    Volume of flow in brachial artery in L/min

    day 1 post access creation

  • Volume flow

    Volume of flow in brachial artery in L/min

    day 2 post access creation

  • Volume flow

    Volume of flow in brachial artery in L/min

    day 3 post access creation

  • Volume flow

    Volume of flow in brachial artery in L/min

    day 4 post access creation

  • Volume flow

    Volume of flow in brachial artery in L/min

    day 5 post access creation

  • Volume flow

    Volume of flow in brachial artery in L/min

    day 6 post access creation

  • Volume flow

    Volume of flow in brachial artery in L/min

    day 7 post access creation

  • Volume flow

    Volume of flow in brachial artery in L/min

    day 14 post access creation

  • Volume flow

    Volume of flow in brachial artery in L/min

    day 21 post access creation

  • Volume flow

    Volume of flow in brachial artery in L/min

    day 28 post access creation

  • Volume flow

    Volume of flow in brachial artery in L/min

    day 60 post access creation

  • Volume flow

    Volume of flow in brachial artery in L/min

    day 90 post access creation

  • brachial artery diameter

    Diameter of the Brachial artery in mm

    day 1 post access creation

  • brachial artery diameter

    Diameter of the Brachial artery in mm

    day 2 post access creation

  • brachial artery diameter

    Diameter of the Brachial artery in mm

    day 3 post access creation

  • brachial artery diameter

    Diameter of the Brachial artery in mm

    day 4 post access creation

  • brachial artery diameter

    Diameter of the Brachial artery in mm

    day 5 post access creation

  • brachial artery diameter

    Diameter of the Brachial artery in mm

    day 6 post access creation

  • brachial artery diameter

    Diameter of the Brachial artery in mm

    day 7 post access creation

  • brachial artery diameter

    Diameter of the Brachial artery in mm

    day 14 post access creation

  • brachial artery diameter

    Diameter of the Brachial artery in mm

    day 21 post access creation

  • brachial artery diameter

    Diameter of the Brachial artery in mm

    day 28 post access creation

  • brachial artery diameter

    Diameter of the Brachial artery in mm

    day 60 post access creation

  • brachial artery diameter

    Diameter of the Brachial artery in mm

    day 90 post access creation

  • Resistive index RI

    Calculation of the Resistive Index of the Brachial artery

    day 1 post access creation

  • Resistive index RI

    Calculation of the Resistive Index of the Brachial artery

    day 2 post access creation

  • Resistive index RI

    Calculation of the Resistive Index of the Brachial artery

    day 3 post access creation

  • Resistive index RI

    Calculation of the Resistive Index of the Brachial artery

    day 4 post access creation

  • Resistive index RI

    Calculation of the Resistive Index of the Brachial artery

    day 5 post access creation

  • Resistive index RI

    Calculation of the Resistive Index of the Brachial artery

    day 6 post access creation

  • Resistive index RI

    Calculation of the Resistive Index of the Brachial artery

    day 7 post access creation

  • Resistive index RI

    Calculation of the Resistive Index of the Brachial artery

    day 14 post access creation

  • Resistive index RI

    Calculation of the Resistive Index of the Brachial artery

    day 21 post access creation

  • Resistive index RI

    Calculation of the Resistive Index of the Brachial artery

    day 28 post access creation

  • Resistive index RI

    Calculation of the Resistive Index of the Brachial artery

    day 60 post access creation

  • Resistive index RI

    Calculation of the Resistive Index of the Brachial artery

    day 90 post access creation

  • Diameter of the efferent vein

    Diameter of the the efferent vein in mm

    day 1 post access creation

  • Diameter of the efferent vein

    Diameter of the the efferent vein in mm

    day 2 post access creation

  • Diameter of the efferent vein

    Diameter of the the efferent vein in mm

    day 3 post access creation

  • Diameter of the efferent vein

    Diameter of the the efferent vein in mm

    day 4 post access creation

  • Diameter of the efferent vein

    Diameter of the the efferent vein in mm

    day 5 post access creation

  • Diameter of the efferent vein

    Diameter of the the efferent vein in mm

    day 6 post access creation

  • Diameter of the efferent vein

    Diameter of the the efferent vein in mm

    day 7 post access creation

  • Diameter of the efferent vein

    Diameter of the the efferent vein in mm

    day 14 post access creation

  • Diameter of the efferent vein

    Diameter of the the efferent vein in mm

    day 21 post access creation

  • Diameter of the efferent vein

    Diameter of the the efferent vein in mm

    day 28 post access creation

  • Diameter of the efferent vein

    Diameter of the the efferent vein in mm

    day 60 post access creation

  • Diameter of the efferent vein

    Diameter of the the efferent vein in mm

    day 90 post access creation

  • Wall thickness of the efferent vein

    Wall thickness of the efferent vein in mm

    day 1 post access creation

  • Wall thickness of the efferent vein

    Wall thickness of the efferent vein in mm

    day 2 post access creation

  • Wall thickness of the efferent vein

    Wall thickness of the efferent vein in mm

    day 3 post access creation

  • Wall thickness of the efferent vein

    Wall thickness of the efferent vein in mm

    day 4 post access creation

  • Wall thickness of the efferent vein

    Wall thickness of the efferent vein in mm

    day 5 post access creation

  • Wall thickness of the efferent vein

    Wall thickness of the efferent vein in mm

    day 6 post access creation

  • Wall thickness of the efferent vein

    Wall thickness of the efferent vein in mm

    day 7 post access creation

  • Wall thickness of the efferent vein

    Wall thickness of the efferent vein in mm

    day 14 post access creation

  • Wall thickness of the efferent vein

    Wall thickness of the efferent vein in mm

    day 21 post access creation

  • Wall thickness of the efferent vein

    Wall thickness of the efferent vein in mm

    day 28 post access creation

  • Wall thickness of the efferent vein

    Wall thickness of the efferent vein in mm

    day 60 post access creation

  • Wall thickness of the efferent vein

    Wall thickness of the efferent vein in mm

    day 90 post access creation

Secondary Outcomes (4)

  • Time of first successful cannulation

    30 and 60 days

  • Successful hemodialysis

    30 and 60 days

  • Primary patency

    6 months

  • Surgeon-Nephrologist access site selection concordance

    At access creation (day 0)

Study Arms (1)

Dialysis

Patients with hemodialysis-dependent end-stage renal disease and a newly created native arteriovenous fistula

Diagnostic Test: Doppler ultrasound study

Interventions

Doppler ultrasound studyDIAGNOSTIC_TEST

Transcutaneous Doppler ultrasound (DUS) study was performed at the mid brachial artery to assess diameter, VF and RI, and at the mid segment of the efferent vein to assess the diameter and wall thickness.

Dialysis

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will recruit patients with end-stage renal disease eligible for native arteriovenous fistula creation for hemodialysis fulfilling the study's inclusion critera.

You may qualify if:

  • Hemodialysis patients
  • new native arteriovenous fistula (AVF)

You may not qualify if:

  • Patients not eligible for AVF creation
  • Patients with non compensated heart failure New York Heart Association stages 3 and 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mediterranean Hospital

Glyfada, Attica, 16675, Greece

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ioannis E Giannikouris, MD, MSc, PhD

    Mediterranean Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Nephrologist

Study Record Dates

First Submitted

January 27, 2021

First Posted

February 3, 2021

Study Start

February 1, 2019

Primary Completion

February 20, 2022

Study Completion

February 20, 2022

Last Updated

March 23, 2022

Record last verified: 2022-03

Locations

GR(1)