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Completed

NCT Number: NCT04736875

Arteriovenous Fistula Maturation Evaluation Study. FAME Study

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

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Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Access Failure Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Native Arteriovenous Fistula Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Access Maturation

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mediterranean Hospital

Glyfada, Attica, 16675, Greece

About this study

This is a prospective, single-center, observational study, investigating the clinical and hemodynamic features of maturation of hemodialysis native arteriovenous fistula (AVF). Hemodynamic features under investigation are the diameter of the feeding brachial artery, volume of flow (VF) measured with transcutaneous Duplex ultrasound (DUS), resistivity index (RI), diameter and wall thickness of the efferent vein, measured at days 1, 2, 3, 4, 5, 6, 7, 14, 21, 30, 60 and 90 post creation. Clinical features of maturation are the time of first access successful cannulation and the performance of three consecutive adequate dialysis sessions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hemodialysis patients
  • new native arteriovenous fistula (AVF)

Exclusion criteria

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

Treatment and study plan

Doppler ultrasound study

Diagnostic 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.

Primary outcomes

  1. Volume flow

    Time frame: day 1 post access creation

    Volume of flow in brachial artery in L/min

  2. Volume flow

    Time frame: day 2 post access creation

    Volume of flow in brachial artery in L/min

  3. Volume flow

    Time frame: day 3 post access creation

    Volume of flow in brachial artery in L/min

  4. Volume flow

    Time frame: day 4 post access creation

    Volume of flow in brachial artery in L/min

  5. Volume flow

    Time frame: day 5 post access creation

    Volume of flow in brachial artery in L/min

  6. Volume flow

    Time frame: day 6 post access creation

    Volume of flow in brachial artery in L/min

  7. Volume flow

    Time frame: day 7 post access creation

    Volume of flow in brachial artery in L/min

  8. Volume flow

    Time frame: day 14 post access creation

    Volume of flow in brachial artery in L/min

  9. Volume flow

    Time frame: day 21 post access creation

    Volume of flow in brachial artery in L/min

  10. Volume flow

    Time frame: day 28 post access creation

    Volume of flow in brachial artery in L/min

  11. Volume flow

    Time frame: day 60 post access creation

    Volume of flow in brachial artery in L/min

  12. Volume flow

    Time frame: day 90 post access creation

    Volume of flow in brachial artery in L/min

  13. brachial artery diameter

    Time frame: day 1 post access creation

    Diameter of the Brachial artery in mm

  14. brachial artery diameter

    Time frame: day 2 post access creation

    Diameter of the Brachial artery in mm

  15. brachial artery diameter

    Time frame: day 3 post access creation

    Diameter of the Brachial artery in mm

  16. brachial artery diameter

    Time frame: day 4 post access creation

    Diameter of the Brachial artery in mm

  17. brachial artery diameter

    Time frame: day 5 post access creation

    Diameter of the Brachial artery in mm

  18. brachial artery diameter

    Time frame: day 6 post access creation

    Diameter of the Brachial artery in mm

  19. brachial artery diameter

    Time frame: day 7 post access creation

    Diameter of the Brachial artery in mm

  20. brachial artery diameter

    Time frame: day 14 post access creation

    Diameter of the Brachial artery in mm

  21. brachial artery diameter

    Time frame: day 21 post access creation

    Diameter of the Brachial artery in mm

  22. brachial artery diameter

    Time frame: day 28 post access creation

    Diameter of the Brachial artery in mm

  23. brachial artery diameter

    Time frame: day 60 post access creation

    Diameter of the Brachial artery in mm

  24. brachial artery diameter

    Time frame: day 90 post access creation

    Diameter of the Brachial artery in mm

  25. Resistive index RI

    Time frame: day 1 post access creation

    Calculation of the Resistive Index of the Brachial artery

  26. Resistive index RI

    Time frame: day 2 post access creation

    Calculation of the Resistive Index of the Brachial artery

  27. Resistive index RI

    Time frame: day 3 post access creation

    Calculation of the Resistive Index of the Brachial artery

  28. Resistive index RI

    Time frame: day 4 post access creation

    Calculation of the Resistive Index of the Brachial artery

  29. Resistive index RI

    Time frame: day 5 post access creation

    Calculation of the Resistive Index of the Brachial artery

  30. Resistive index RI

    Time frame: day 6 post access creation

    Calculation of the Resistive Index of the Brachial artery

  31. Resistive index RI

    Time frame: day 7 post access creation

    Calculation of the Resistive Index of the Brachial artery

  32. Resistive index RI

    Time frame: day 14 post access creation

    Calculation of the Resistive Index of the Brachial artery

  33. Resistive index RI

    Time frame: day 21 post access creation

    Calculation of the Resistive Index of the Brachial artery

  34. Resistive index RI

    Time frame: day 28 post access creation

    Calculation of the Resistive Index of the Brachial artery

  35. Resistive index RI

    Time frame: day 60 post access creation

    Calculation of the Resistive Index of the Brachial artery

  36. Resistive index RI

    Time frame: day 90 post access creation

    Calculation of the Resistive Index of the Brachial artery

  37. Diameter of the efferent vein

    Time frame: day 1 post access creation

    Diameter of the the efferent vein in mm

  38. Diameter of the efferent vein

    Time frame: day 2 post access creation

    Diameter of the the efferent vein in mm

  39. Diameter of the efferent vein

    Time frame: day 3 post access creation

    Diameter of the the efferent vein in mm

  40. Diameter of the efferent vein

    Time frame: day 4 post access creation

    Diameter of the the efferent vein in mm

  41. Diameter of the efferent vein

    Time frame: day 5 post access creation

    Diameter of the the efferent vein in mm

  42. Diameter of the efferent vein

    Time frame: day 6 post access creation

    Diameter of the the efferent vein in mm

  43. Diameter of the efferent vein

    Time frame: day 7 post access creation

    Diameter of the the efferent vein in mm

  44. Diameter of the efferent vein

    Time frame: day 14 post access creation

    Diameter of the the efferent vein in mm

  45. Diameter of the efferent vein

    Time frame: day 21 post access creation

    Diameter of the the efferent vein in mm

  46. Diameter of the efferent vein

    Time frame: day 28 post access creation

    Diameter of the the efferent vein in mm

  47. Diameter of the efferent vein

    Time frame: day 60 post access creation

    Diameter of the the efferent vein in mm

  48. Diameter of the efferent vein

    Time frame: day 90 post access creation

    Diameter of the the efferent vein in mm

  49. Wall thickness of the efferent vein

    Time frame: day 1 post access creation

    Wall thickness of the efferent vein in mm

  50. Wall thickness of the efferent vein

    Time frame: day 2 post access creation

    Wall thickness of the efferent vein in mm

  51. Wall thickness of the efferent vein

    Time frame: day 3 post access creation

    Wall thickness of the efferent vein in mm

  52. Wall thickness of the efferent vein

    Time frame: day 4 post access creation

    Wall thickness of the efferent vein in mm

  53. Wall thickness of the efferent vein

    Time frame: day 5 post access creation

    Wall thickness of the efferent vein in mm

  54. Wall thickness of the efferent vein

    Time frame: day 6 post access creation

    Wall thickness of the efferent vein in mm

  55. Wall thickness of the efferent vein

    Time frame: day 7 post access creation

    Wall thickness of the efferent vein in mm

  56. Wall thickness of the efferent vein

    Time frame: day 14 post access creation

    Wall thickness of the efferent vein in mm

  57. Wall thickness of the efferent vein

    Time frame: day 21 post access creation

    Wall thickness of the efferent vein in mm

  58. Wall thickness of the efferent vein

    Time frame: day 28 post access creation

    Wall thickness of the efferent vein in mm

  59. Wall thickness of the efferent vein

    Time frame: day 60 post access creation

    Wall thickness of the efferent vein in mm

  60. Wall thickness of the efferent vein

    Time frame: day 90 post access creation

    Wall thickness of the efferent vein in mm

Secondary outcomes

  1. Time of first successful cannulation

    Time frame: 30 and 60 days

    Time period between access creation and first successful cannulation for hemodialysis

  2. Successful hemodialysis

    Time frame: 30 and 60 days

    Three consecutive adequate hemodialysis sessions based on measurement of single pool kt/V

  3. Primary patency

    Time frame: 6 months

    Percentage of total patent arteriovenous fistulae without the need of additional interventions assessed by transcutaneous dopler ultrasound

  4. Surgeon-Nephrologist access site selection concordance

    Time frame: At access creation (day 0)

    Record of the opinion regarding the site of vascular access creation between the nephrologist performing preoperative mapping and the surgeon performing access creation with the use of a questionaire

Sponsors and collaborators

Lead sponsor

Medifil AE

Other

Collaborators

  • Democritus University of Thrace
  • National and Kapodistrian University of Athens

Registry information

Official study title

Study of the Hemodynamic and Clinical Maturation of the Native Arteriovenous Fistula for Hemodialysis

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 3, 2021
Registry last updated
Mar 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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