Endothelial Function and Arterio-Venous Fistula Maturation

NCT ID: NCT01604473

Last Updated: 2022-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2014-04-29

Brief Summary

An arterio-venous fistula is a surgical procedure that supports access for people undergoing hemodialysis (HD) for End Stage Renal Disease (ESRD). This observational pilot study seeks to better understand the factors that contribute to the successful maturation of an arterio-venous fistula. A primary aim of this study is to see if endothelial function (the biochemical events initiated by cells lining the arteries) is associated with successful maturation. Other aims include determining if pro-inflammatory markers in the blood or evidence of gene expression are associated with successful maturation.

Detailed Description

Current practice guidelines stipulate that 65% of all prevalent ESRD patients should receive HD through some sort of arterio-venous fistula (AVF). An AVF is a subcutaneous, permanent vascular access created surgically by connecting a vein with an artery and is the preferred mode of access due to lower rates of infection or thrombosis compared to prosthetic grafts or tunneled lines. An AVF is mature if it can sustain high quality HD. However, rates of primary failure (the inability of an AVF to sustain HD) are high, ranging from 40-70%. Traditional coronary risk factors such as hypertension, hypercholesterolemia, and diabetes mellitus, have limited ability to allow surgeons to predict which AVFs will mature.

One possible explanation involves vascular remodeling, the structural changes which occur in a blood vessel in response to hemodynamic stimuli. The endothelial, lying at the interface of the vessel wall and flowing blood, is a "biosensor", responding to changes in blood flow and pressure. It initiates a complex biological response including cellular proliferation and migration, matrix degradation, and cellular apoptosis. This longitudinal, observational study hypothesizes that endothelial function is a critical modulator of AVF maturation. Specifically, that patients with inflammation will have impaired endothelial function and demonstrate less significant remodeling than others.

Conditions

Chronic Kidney Disease

Study Design

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

Study Groups

Chronic Kidney Disease

Individuals with Chronic Kidney Disease stages IV or V anticipating the need for hemodialysis access through an arterio-venous fistula.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Chronic Kidney Disease classification Stage IV or V
• Adequate quality cephalic or basilic vein based on pre-operative assessment
• Able to provide written informed consent
• Able to travel to the SFVA Medical Center or UCSF Medical Center for follow-up examination

Exclusion Criteria

• Age >90 or < 18 years
• Diagnosed hypercoaguble state
• Recent surgery or other major illness or infection within 6 weeks
• Use of immunosuppresive medication
• History or organ transplantation
• Pregnancy or plans to become pregnant
• Estimated life expectancy is less than 1 year

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Warren J Gasper, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

San Francisco VA Medical Center

San Francisco, California, United States

University of California, San Francisco Medical Center

San Francisco, California, United States

Countries

United States

Other Identifiers

10-02538

Identifier Type: -

Identifier Source: org_study_id