Arteriovenous Fistula Maturation Evaluation Study. FAME Study

• Sponsor: Medifil AE (Other)
• Overall Status: Completed
• CT.gov ID: NCT04736875
• Collaborator: National and Kapodistrian University of Athens (Other), Democritus University of Thrace (Other)
• Enrollment: 86
• Location: 1
• Actual Duration (Months): 36.6
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
End-stage Renal Disease; Hemodialysis Access Failure; Vascular Access Maturation; Native Arteriovenous Fistula	Diagnostic Test: Doppler ultrasound study

Detailed Description

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 86 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Study of the Hemodynamic and Clinical Maturation of the Native Arteriovenous Fistula for Hemodialysis
• Actual Study Start Date: Feb 1, 2019
• Actual Primary Completion Date: Feb 20, 2022
• Actual Study Completion Date: Feb 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Dialysis Patients with hemodialysis-dependent end-stage renal disease and a newly created native arteriovenous fistula	Diagnostic Test: Doppler ultrasound study; 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.

Outcome Measures

Primary Outcome Measures

1. Volume flow [day 1 post access creation]

   Volume of flow in brachial artery in L/min

2. Volume flow [day 2 post access creation]

   Volume of flow in brachial artery in L/min

3. Volume flow [day 3 post access creation]

   Volume of flow in brachial artery in L/min

4. Volume flow [day 4 post access creation]

   Volume of flow in brachial artery in L/min

5. Volume flow [day 5 post access creation]

   Volume of flow in brachial artery in L/min

6. Volume flow [day 6 post access creation]

   Volume of flow in brachial artery in L/min

7. Volume flow [day 7 post access creation]

   Volume of flow in brachial artery in L/min

8. Volume flow [day 14 post access creation]

   Volume of flow in brachial artery in L/min

9. Volume flow [day 21 post access creation]

   Volume of flow in brachial artery in L/min

10. Volume flow [day 28 post access creation]

    Volume of flow in brachial artery in L/min

11. Volume flow [day 60 post access creation]

    Volume of flow in brachial artery in L/min

12. Volume flow [day 90 post access creation]

    Volume of flow in brachial artery in L/min

13. brachial artery diameter [day 1 post access creation]

    Diameter of the Brachial artery in mm

14. brachial artery diameter [day 2 post access creation]

    Diameter of the Brachial artery in mm

15. brachial artery diameter [day 3 post access creation]

    Diameter of the Brachial artery in mm

16. brachial artery diameter [day 4 post access creation]

    Diameter of the Brachial artery in mm

17. brachial artery diameter [day 5 post access creation]

    Diameter of the Brachial artery in mm

18. brachial artery diameter [day 6 post access creation]

    Diameter of the Brachial artery in mm

19. brachial artery diameter [day 7 post access creation]

    Diameter of the Brachial artery in mm

20. brachial artery diameter [day 14 post access creation]

    Diameter of the Brachial artery in mm

21. brachial artery diameter [day 21 post access creation]

    Diameter of the Brachial artery in mm

22. brachial artery diameter [day 28 post access creation]

    Diameter of the Brachial artery in mm

23. brachial artery diameter [day 60 post access creation]

    Diameter of the Brachial artery in mm

24. brachial artery diameter [day 90 post access creation]

    Diameter of the Brachial artery in mm

25. Resistive index RI [day 1 post access creation]

    Calculation of the Resistive Index of the Brachial artery

26. Resistive index RI [day 2 post access creation]

    Calculation of the Resistive Index of the Brachial artery

27. Resistive index RI [day 3 post access creation]

    Calculation of the Resistive Index of the Brachial artery

28. Resistive index RI [day 4 post access creation]

    Calculation of the Resistive Index of the Brachial artery

29. Resistive index RI [day 5 post access creation]

    Calculation of the Resistive Index of the Brachial artery

30. Resistive index RI [day 6 post access creation]

    Calculation of the Resistive Index of the Brachial artery

31. Resistive index RI [day 7 post access creation]

    Calculation of the Resistive Index of the Brachial artery

32. Resistive index RI [day 14 post access creation]

    Calculation of the Resistive Index of the Brachial artery

33. Resistive index RI [day 21 post access creation]

    Calculation of the Resistive Index of the Brachial artery

34. Resistive index RI [day 28 post access creation]

    Calculation of the Resistive Index of the Brachial artery

35. Resistive index RI [day 60 post access creation]

    Calculation of the Resistive Index of the Brachial artery

36. Resistive index RI [day 90 post access creation]

    Calculation of the Resistive Index of the Brachial artery

37. Diameter of the efferent vein [day 1 post access creation]

    Diameter of the the efferent vein in mm

38. Diameter of the efferent vein [day 2 post access creation]

    Diameter of the the efferent vein in mm

39. Diameter of the efferent vein [day 3 post access creation]

    Diameter of the the efferent vein in mm

40. Diameter of the efferent vein [day 4 post access creation]

    Diameter of the the efferent vein in mm

41. Diameter of the efferent vein [day 5 post access creation]

    Diameter of the the efferent vein in mm

42. Diameter of the efferent vein [day 6 post access creation]

    Diameter of the the efferent vein in mm

43. Diameter of the efferent vein [day 7 post access creation]

    Diameter of the the efferent vein in mm

44. Diameter of the efferent vein [day 14 post access creation]

    Diameter of the the efferent vein in mm

45. Diameter of the efferent vein [day 21 post access creation]

    Diameter of the the efferent vein in mm

46. Diameter of the efferent vein [day 28 post access creation]

    Diameter of the the efferent vein in mm

47. Diameter of the efferent vein [day 60 post access creation]

    Diameter of the the efferent vein in mm

48. Diameter of the efferent vein [day 90 post access creation]

    Diameter of the the efferent vein in mm

49. Wall thickness of the efferent vein [day 1 post access creation]

    Wall thickness of the efferent vein in mm

50. Wall thickness of the efferent vein [day 2 post access creation]

    Wall thickness of the efferent vein in mm

51. Wall thickness of the efferent vein [day 3 post access creation]

    Wall thickness of the efferent vein in mm

52. Wall thickness of the efferent vein [day 4 post access creation]

    Wall thickness of the efferent vein in mm

53. Wall thickness of the efferent vein [day 5 post access creation]

    Wall thickness of the efferent vein in mm

54. Wall thickness of the efferent vein [day 6 post access creation]

    Wall thickness of the efferent vein in mm

55. Wall thickness of the efferent vein [day 7 post access creation]

    Wall thickness of the efferent vein in mm

56. Wall thickness of the efferent vein [day 14 post access creation]

    Wall thickness of the efferent vein in mm

57. Wall thickness of the efferent vein [day 21 post access creation]

    Wall thickness of the efferent vein in mm

58. Wall thickness of the efferent vein [day 28 post access creation]

    Wall thickness of the efferent vein in mm

59. Wall thickness of the efferent vein [day 60 post access creation]

    Wall thickness of the efferent vein in mm

60. Wall thickness of the efferent vein [day 90 post access creation]

    Wall thickness of the efferent vein in mm

Secondary Outcome Measures

1. Time of first successful cannulation [30 and 60 days]

   Time period between access creation and first successful cannulation for hemodialysis

2. Successful hemodialysis [30 and 60 days]

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

3. Primary patency [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Hemodialysis patients

2. new native arteriovenous fistula (AVF)

Exclusion Criteria:

1. Patients not eligible for AVF creation

2. Patients with non compensated heart failure New York Heart Association stages 3 and 4

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mediterranean Hospital	Glyfáda	Attiki	Greece	16675

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Ioannis E Giannikouris, MD, MSc, PhD, Mediterranean Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ioannis Emmanouel Giannikouris, Director Nephrologist, Medifil AE
• ClinicalTrials.gov Identifier: NCT04736875
• Other Study ID Numbers: 3
• First Posted: Feb 3, 2021
• Last Update Posted: Mar 23, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ioannis Emmanouel Giannikouris, Director Nephrologist, Medifil AE: hemodialysis; native arteriovenous fistula; maturation; feeding artery; efferent vein
• Additional relevant MeSH terms: Kidney Failure, Chronic; Arteriovenous Fistula; Fistula

Study Results

No Results Posted as of Mar 23, 2022