O-GlcNac Modified Proteomics Study of the Maturation of Hemodialysis Arteriovenous

We divided into three parts to carry out. Firstly, evidence the pre-existing fibrosis in vein of AVF failure patients. investigation of expression, the role, and the mechanism by which the identified O-GlcNAac proteins promote, maturation of AV fistula. Finally, ddress and compare the proteomics differentiation between failure and maturation of AVF patients.

Study Overview

• Status: Completed
• Conditions: Arteriovenous Fistula Occlusion
• Intervention / Treatment: Other: No intervention

Detailed Description

End stage renal disease (ESRD) patients requires hemodialysis to maintain bloodstream functions. Before the hemodialysis, the patients requires a long-term vascular access, which best choice is Arteriovenous fistulas (AVF). However, 1/3 of patients were failure in AVF maturation, and it is still unknown. Our preliminary data have shown that pre-exisiting fibrosis in vein of AVF failure. Here, we will investigate whether pre-existing fibrosis of vein is asssociated with circulating fibrocytes in AVF failure, and further to address molecular mechanism of fibrocytes differentiation. We will divide into three parts to carry out. Firstly, evidence the pre-existing fibrosis in vein of AVF failure patients. Secondary, investigation of expression, the role, and the mechanism by which the identified O-GlcNAac proteins promote, maturation of AV fistula. Finally, address and compare the proteomics differentiation between failure and maturation of AVF patients. We hope that through this project, we can obtain signifiture molecules for precision detection and solve the current clinical unmet need.

• Study Type: Observational
• Enrollment (Actual): 126

Contacts and Locations

Study Locations

• Taiwan
  • No.7, Chung Shan S. Rd
    • Taipei, No.7, Chung Shan S. Rd, Taiwan, 10002
      • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Age of 20 and older adult patients, and preoperatively clinical and ultrasound assessment of the arm vessels are fisible 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.

Description

Inclusion Criteria:

• Age of 20 and older adult patients, and preoperatively clinical and ultrasound assessment of the arm vessels are fisible 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:

• The patient refused to join the study
• Too weak
• Serious heart failure
• Unconsciousness
• Bedridden for long time
• systemic lupus erythematosus(SLE), or other known autoimmune diseases
• The physician excludes the possibility of creating a wrist HDAVF before surgery
• Surgeon preoperatively identifies vessel inadequacy for the creation of a wrist HDAVF
• Choose a site other than the wrist for surgery
• Unexpected negative complications happen during surgery that prevent the completion of a wirst HDAVF

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Matured; It is defined as the target HDAVF can be used	Other: No intervention; No intervention
Non-matured; RC-AVF underwent additional intervention after 90 days of observation	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The diameter of each passage of the passage vein (forearm head vein) of the arterial and venous access within three months	Comparison of the various methods to achieve within three months the checkpoint path diameter increase rate (two time points measurement difference).	Postoperative Three months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Actual): October 26, 2020
• Study Completion (Actual): October 26, 2020

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: April 16, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: proteomics; Arteriovenous Fistula; vascular smooth muscle; histological technique; O-GlcNac
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: 201712231RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No