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

Arteriovenous Fistula Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05832476
• Other study ID #: 201712231RINC
• Status: Completed
• Start date: March 28, 2018
• Est. completion date: October 26, 2020

Study information

• Verified date: January 2018
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 26, 2020
• Est. primary completion date: October 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Arteriovenous Fistula Occlusion
• Fistula

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei	No.7, Chung Shan S. Rd

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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