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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05832476
Collaborator
(none)
126
1
31
4.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
126 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
O-GlcNac Modified Proteomics Study of the Maturation of Hemodialysis Arteriovenous
Actual Study Start Date :
Mar 28, 2018
Actual Primary Completion Date :
Oct 26, 2020
Actual Study Completion Date :
Oct 26, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. The diameter of each passage of the passage vein (forearm head vein) of the arterial and venous access within three months [Postoperative Three months]

    Comparison of the various methods to achieve within three months the checkpoint path diameter increase rate (two time points measurement difference).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei No.7, Chung Shan S. Rd Taiwan 10002

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

  • Principal Investigator: Chih-Yang Chan, phd, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05832476
Other Study ID Numbers:
  • 201712231RINC
First Posted:
Apr 27, 2023
Last Update Posted:
Apr 27, 2023
Last Verified:
Jan 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Taiwan University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2023