Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06480331

Radiation Free Fistuloplasty is the Way Forward

Led by University of Malaya · Updated on 2024-06-28

54

Participants Needed

2

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to study effectiveness of ultrasound-guided fistuloplasty in comparison to conventional fistuloplasty in patients with arteriovenous access flow dysfunction. The main question it aims to answer is: To investigate patencies in patients with arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty at 6 months Participants will: * be randomized equally to ultrasound-guided fistuloplasty group and fluoroscopy-guided fistuloplasty group. * visit clinic at one month, three month \& six months for checkups and tests.

CONDITIONS

Official Title

Radiation Free Fistuloplasty is the Way Forward

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient able to comprehend English or Malay language.
  • Patient aged ≥18 years and ≤80 years.
  • Patient is willing to comply with protocol.
  • Native AVF that is able to provide prescribed dialysis consistently with 2 needles for >2/3 of dialysis sessions within 4 consecutive weeks.
  • Patient has a reasonable expectation of remaining on haemodialysis for 6 months.
  • Dampened thrill or pulsatile flow.
  • Volume flow (VF) <500 ml/min.
  • Severe stenosis (>50%) of arteriovenous (AV) access measured on color image and confirmed by peak systolic velocity (PSV) ratio of ≥3 in the inflow artery, anastomosis, or in the outflow vein.
Not Eligible

You will not qualify if you...

  • Prior history of fistuloplasty.
  • Thrombosed or completely occluded fistula or outflow vein.
  • Non-mature AVF.
  • Arteriovenous grafts.
  • Suspected central vein stenosis/ cephalic arch stenosis - arm edema or Doppler detected suspicion of the same.
  • Non consenting patient.
  • Metastatic cancer or terminal medical condition.
  • Limited life expectancy (<6 months).
  • Blood coagulation disorders (haemophilia/ Von Willebrand disease/ clotting factor deficiencies/ liver disease).
  • Connective tissue disease (rheumatoid arthritis/ lupus).
  • Sepsis or active infection.
  • Planned access abandonment within 6 months (eg, peritoneal dialysis or transplant).
  • Pregnant women or women of childbearing potential who are not following an effective method of contraception.
  • Allergy or other known contraindication to iodinated media contrast.
  • Patient enrolled in another access maintenance trial.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Kuala Lumpur Hospital, Jalan Pahang,

Kuala Lumpur, Kuala Lumpur, Malaysia, 50586

Actively Recruiting

2

University Malaya Medical Centre, Jln Profesor Diraja Ungku Aziz, Seksyen 13,

Petaling Jaya, Kuala Lumpur, Malaysia, 50603

Actively Recruiting

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Research Team

E

Ehab Bin Said

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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