Clinical and Mechanistic Research on Autogenous Arteriovenous Fistula in Hemodialysis Patients

NCT ID: NCT07058441

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2027-01-01

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.

Detailed Description

This observational study aims to investigate the long-term clinical outcomes and molecular mechanisms underlying autogenous arteriovenous fistula (AVF) maturation failure in uremic patients, with the primary goal of developing a precision prediction model integrating clinical, imaging, and biomarker data while also identifying key molecular targets regulating AVF maturation. Conducted as a single-center prospective study at Shanghai Tenth People's Hospital, the research will enroll 300 ESRD patients undergoing first-time AVF creation, collecting comprehensive multi-omics data including clinical parameters (demographics, comorbidities, laboratory tests), ultrasound imaging (vessel diameter, blood flow measurements), and molecular biomarkers (miRNAs, cytokines, vascular remodeling proteins). Using advanced machine learning techniques like Random Forest and XGBoost, the study will construct a predictive model for AVF maturation failure based on KDOQI criteria (blood flow <600 mL/min, diameter <6 mm, or depth >6 mm at 6 weeks), while parallel mechanistic investigations will employ WGCNA and Cox regression analyses to elucidate critical molecular pathways such as VEGF/TGF-β signaling and potential therapeutic targets including ALPL and Eph-B4. The study adheres to strict ethical guidelines (Helsinki Declaration, GCP standards) and includes rigorous statistical planning with a sample size calculated to ensure adequate power (300 patients yielding 110 expected events), employing AUC analysis for model discrimination and standard statistical tests for group comparisons. Expected outcomes include the development of a clinically applicable prediction tool (targeting software copyright), 2-3 high-impact SCI publications, and identification of novel therapeutic targets, with the entire project spanning from patient recruitment (2025.07-2026.07) through data analysis and manuscript preparation (2026.11-2027.01), ultimately aiming to significantly improve AVF management through its innovative combination of multi-omics integration and machine learning approaches.

Conditions

Arteriovenous Fistula Maturation Failure in End-stage Renal Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years

2. Diagnosed with chronic kidney disease stage 5 (ESRD) and scheduled for first-time autogenous AVF creation

3. No severe coagulation disorders or vascular malformations

4. Willing to provide written informed consent

5. Planned hemodialysis at the study center

Exclusion Criteria

1. Previous AVF surgery on the ipsilateral limb

2. Ipsilateral central venous stenosis or significant venous outflow obstruction

3. Active malignancy (except localized non-melanoma skin cancer)

4. Active infection at the surgical site

5. Life expectancy <1 year

6. Pregnancy or lactation

7. Participation in other interventional trials

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ai Peng

OTHER

Sponsor Role: lead

Responsible Party

Ai Peng

Director of the department of Nephrology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Shanghai, , China

Countries

China

Other Identifiers

25K118

Identifier Type: -

Identifier Source: org_study_id