Clinical and Mechanistic Research on Autogenous Arteriovenous Fistula in Hemodialysis Patients

NCT07058441 | Active Not Recruiting

• 1 other identifier: 25K118
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the long-term clinical outcomes and molecular mechanisms of autogenous arteriovenous fistula (AVF) maturation failure in uremic patients. The primary goal is to develop a precision prediction model integrating clinical, imaging, and biomarker data, while secondary objectives focus on identifying key molecular targets regulating AVF maturation.

Conditions

Arteriovenous Fistula Maturation Failure in End-stage Renal Disease

Keywords

Arteriovenous fistula maturation failure

Outcome Measures

Primary Outcomes (1)

• Arteriovenous fistula maturation failure rate

  Failure to meet KDOQI criteria at 6 weeks post-operation (blood flow \<600 mL/min, venous diameter \<6 mm, OR subcutaneous depth \>6 mm) AND inability to sustain hemodialysis (2 sessions/week)

  6 weeks and 6 months post-surgery

Study Arms (1)

Single observational cohort of end-stage renal disease patients receiving initial autogenous arterio

This is an observational study with no investigational interventions. Standard clinical AVF surgical procedures will be performed per hospital protocols.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will enroll 300 adult ESRD patients undergoing initial autogenous arteriovenous fistula (AVF) creation at Shanghai Tenth People's Hospital. The population represents typical hemodialysis candidates with end-stage renal failure requiring vascular access. Participants will be recruited consecutively from nephrology and vascular surgery clinics, reflecting real-world clinical practice. The cohort will include patients with varied comorbidities (e.g., diabetes, hypertension) but exclude those with conditions that may confound AVF maturation assessment (prior access surgery, limited life expectancy). All patients will receive standard preoperative evaluation including vascular mapping ultrasound.

You may qualify if:

• Age ≥18 years
• Diagnosed with chronic kidney disease stage 5 (ESRD) and scheduled for first-time autogenous AVF creation
• No severe coagulation disorders or vascular malformations
• Willing to provide written informed consent
• Planned hemodialysis at the study center

You may not qualify if:

• Previous AVF surgery on the ipsilateral limb
• Ipsilateral central venous stenosis or significant venous outflow obstruction
• Active malignancy (except localized non-melanoma skin cancer)
• Active infection at the surgical site
• Life expectancy \<1 year
• Pregnancy or lactation
• Participation in other interventional trials

Sponsors & Collaborators

• Ai Peng: lead

Study Sites (1)

Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital

Shanghai, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Vascular tissues will be preserved for histopathological examination

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the department of Nephrology

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: October 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)