CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Upper arm arteriovenous graft surgery +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03545113
NCT03545113N/ACompleted

A Randomized Pilot Study Comparing Graft-first to Fistula-first Strategies in Older Patients With Incident End-stage Kidney Disease

Wake Forest University Health Sciences·interventional·Posted Jun 4, 2018·Updated Nov 21, 2022

In Brief

A clinical study evaluating Upper arm arteriovenous graft surgery and Upper arm arteriovenous fistula surgery for Kidney Diseases. Completed, enrolled 44 participants across 1 site.

Detailed Summary

Many older adults require hemodialysis for advanced chronic kidney disease, but it is not clear which permanent vascular access method (fistula or graft) is best with respect to access effectiveness and patient satisfaction. In this pilot study, the study team will test the hypothesis that older adults undergoing graft access placement will more effectively transition from catheter-based to arteriovenous access-based hemodialysis; have fewer following vascular access procedures; have better upper extremity function; have better self-sufficiency with daily activities; and better health-related quality of life compared to those who undergo arteriovenous fistula access placement. The study will establish feasibility of randomizing older adults to the two types of arteriovenous access surgeries; evaluate relationships between measurements of pre-operative physical function and vascular access development; compare vascular access outcomes between the two groups; and gather longitudinal assessments of upper extremity muscle strength, performance of activities of daily living, and patients' reports of satisfaction with their vascular access and quality of life.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Diseases
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 4, 2018
Enrollment StartSep 4, 2018
Primary CompletionFeb 22, 2021
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 8.1 years ago

Interventions

Upper arm arteriovenous graft surgeryprocedure

Creation of arteriovenous graft vascular access for hemodialysis

Upper arm arteriovenous fistula surgeryprocedure

Creation of arteriovenous fistula vascular access for hemodialysis