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临床试验/NCT07058441
NCT07058441进行中(未招募)不适用

Clinical and Mechanistic Research on Autogenous Arteriovenous Fistula in Hemodialysis Patients

Ai Peng1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100
试验地点
1
主要终点
Arteriovenous fistula maturation failure rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

Arteriovenous fistula maturation failure rate

时间窗: 6 weeks and 6 months post-surgery

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)

次要结局

未报告次要终点

研究者

发起方
Ai Peng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ai Peng

Director of the department of Nephrology

Shanghai 10th People's Hospital

研究点 (1)

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