RECRUITING

Hemodialysis in the Elderly (70yrs & Older)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This will be a prospective, single institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing autologous arteriovenous fistula versus hemodialysis access grafts in the elderly. The target sample size will include enrollment of 270 patients over a period of 5 years. The creation of an autologous arteriovenous fistula or placement of a hemodialysis access graft constitutes the two arms of the study.

Official Title

A Randomized Controlled Comparative Study on Efficacy and Cost-effectiveness of Autologous Arteriovenous Fistulas Versus Hemodialysis Access Grafts in Elderly Patients

Quick Facts

Study Start:2016-01-28
Study Completion:2025-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03065972

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged ≥70 years of all ethnicities, and;
  2. * Have vascular anatomy amenable to arteriovenous fistula creation, and;
  3. * Diagnosed with End-stage Renal Disease stage 4 (GFR 15-29 ml/min 1.73m2) or stage 5 (GFR \<15ml/min 1.73m2) as per the National Kidney Foundation guidelines needing vascular access for hemodialysis; or,
  4. * Currently undergoing hemodialysis with a failure of previous access; or,
  5. * Expected to undergo hemodialysis within 6 months of presentation.
  1. * Unable or refuse to abide with follow-up; or,
  2. * Known hypercoagulability syndrome or a bleeding disorder; or,
  3. * Intraoperative decision was made in favor of fistula instead of graft; or,
  4. * Active infections; or,
  5. * Evidence or suspicion of central vein stenosis but shall be included if a central vein catheter or pacemaker is implanted as long as the patient had a venogram within past 6 months.

Contacts and Locations

Study Contact

Bright Benfor, MD
CONTACT
713-441-0147
bbenfor@houstonmethodist.org
Bevin A Lopez, MS,CEP,CCRP
CONTACT
346-320-7421
balopez@houstonmethodist.org

Principal Investigator

Eric K Peden, MD
PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute

Study Locations (Sites)

Houston Methodist Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: E. Peden, MD

  • Eric K Peden, MD, PRINCIPAL_INVESTIGATOR, The Methodist Hospital Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-01-28
Study Completion Date2025-02

Study Record Updates

Study Start Date2016-01-28
Study Completion Date2025-02

Terms related to this study

Keywords Provided by Researchers

  • kidney disease
  • vascular access
  • graft
  • fistula
  • hemodialysis
  • dialysis

Additional Relevant MeSH Terms

  • Kidney Disease
  • Kidney Failure
  • Chronic Kidney Disease