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NCT03545113 · ClinicalTrials.gov registry record · NA

Graft-first Versus Fistula-first in Older Patients With End-stage Kidney Disease

A NA study, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
NA
Development phase
44
Enrollment target

NCT03545113: Completed NA study, sponsored by Wake Forest University Health Sciences.

NCT03545113 is a NA study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 44 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03545113, a NA study, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
NA
Development phase
44 participants
Enrollment target

Study 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.

Primary Outcome

Proportion of screened participants deemed eligible for randomization.

Interventions

  • PROCEDURE Upper arm arteriovenous graft surgery
  • PROCEDURE Upper arm arteriovenous fistula surgery

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2018-09-04
Est. Completion 2021-02-22
Phase NA
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT03545113 record still lists

NCT03545113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Upper arm arteriovenous graft surgery is the first listed.

NCT03545113 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03545113 about?

NCT03545113 is a clinical study titled "Graft-first Versus Fistula-first in Older Patients With End-stage Kidney Disease". 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 adu...

What is the current status of trial NCT03545113?

This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2018-09-04. Estimated completion is 2021-02-22.

What interventions are being tested in trial NCT03545113?

The interventions under investigation include: Upper arm arteriovenous graft surgery (PROCEDURE), Upper arm arteriovenous fistula surgery (PROCEDURE).

Who is sponsoring clinical trial NCT03545113?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03545113's enrollment target sits among peer trials

44 1423rd of 2000 higher than 566 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03545113, the US trial registry maintained by the National Library of Medicine. NCT03545113 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.