Predicting Arteriovenous Fistula Maturation Using Inflammatory Markers
Inflammatory Marker and Pre-existing Venous Fibrosis to Predict AVF Mal-maturation
This study is testing if certain inflammation markers can help predict how well arteriovenous fistulas will mature in patients with end-stage renal disease who need dialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT05136859 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between inflammation and pre-existing venous fibrosis in predicting the maturation of arteriovenous fistulas (AVFs) in patients with end-stage renal disease. It aims to analyze blood and tissue samples to assess the impact of these factors on AVF success rates. The research focuses on understanding how perivascular fat around the cephalic vein may influence AVF maturation, which is critical for effective hemodialysis access. By identifying these predictors, the study seeks to improve outcomes for patients requiring vascular access for dialysis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 and older who are undergoing preoperative assessment for the creation of a native hemodialysis arteriovenous fistula.
Not a fit: Patients with serious heart failure, autoimmune diseases, or those who are bedridden may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for ensuring the maturation of arteriovenous fistulas, enhancing the quality of life for patients undergoing hemodialysis.
How similar studies have performed: While there have been studies on AVF maturation, this specific approach focusing on inflammatory markers and pre-existing fibrosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age of 20 and older adult patients. 2. preoperatively clinical and ultrasound assessment of the arm vessels are visible for the creation of a native HDAVF that include：the augmented diameters of the veins is \> 2.0 mm and the diameter of the radial artery is\> 2.0 mm. Besides, there is no obvious stenosis of vessels in the forearm. Exclusion Criteria: 1. The patient refused to join the study 2. serious heart failure (Physicians identify insufficient cardiac output that may affect sacral blood flow development after surgery) 3. Unconsciousness 4. Bedridden for long time 5. systemic lupus erythematosus(SLE), or other known autoimmune diseases 6. The physician excludes the possibility of creating a wrist HDAVF before surgery 7. Surgeon preoperatively identifies vessel inadequacy for the creation of a wrist HDAVF 8. Choose a site other than the wrist for surgery 9. Unexpected complications happen during the surgery that prevent the completion of a wrist HDAVF
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Chih-Yang Chan, PhD
- Email: chanchihyang@gmail.com
- Phone: +886972651147
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.