Trial of Fistula Versus Graft in Elderly Patients

NCT03668002 | Terminated DMC

• 1 other identifier: PRO17100473
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This open-label pilot randomized controlled trial will test the feasibility and safety of randomizing patients over 65 years old who start hemodialysis with a tunneled dialysis catheter (TDC), and are eligible to receive either arteriovenous fistula (AVF) or arteriovenous graft (AVG), to an AVF strategy (comparator) or to an AVG strategy (intervention). The primary outcome is feasibility, which we will assess by measuring: (1) the proportion of randomized participants who receive the assigned arteriovenous access; and (2) the annual rate of enrollment in the study, accounting for the number of surgeons who participate. Secondary outcomes will include perioperative morbidity and mortality, catheter removal rates, additional procedures performed, and the reasons a patient may not receive the assigned AV access.

Conditions

End Stage Renal Disease; Arteriovenous Fistula; Arteriovenous Graft

Keywords

Fistula vs. Graft

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects that received assigned AV access (AVF vs. AVG)

  Adherence to assigned AV access (AVF vs. AVG) during randomization will be measured, expressed as a proportion of all subjects randomized.

  12 months

Secondary Outcomes (1)

• Rate of accrual of subjects to the study

  12 months

Study Arms (2)

Arteriovenous Fistula (AVF)

PLACEBO COMPARATOR

If the participant is randomized to the AVF arm of the trial, the surgeon will connect an artery to a vein in the upper extremity, without using artificial material as conduit.

Procedure: Arteriovenous Fistula (AVF)

Arteriovenous Graft (AVG)

ACTIVE COMPARATOR

If the participant is randomized to the AVG arm of the trial, the surgeon will place a synthetic graft connecting an artery and vein under the skin in an upper extremity.

Procedure: Arteriovenous Graft (AVG)

Interventions

Arteriovenous Fistula (AVF) PROCEDURE

If the participant is randomized to the AVF arm of the trial, the surgeon will connect an artery to a vein in the upper extremity, without using artificial material as conduit.

Arteriovenous Fistula (AVF)

Arteriovenous Graft (AVG) PROCEDURE

If the participant is randomized to the AVG arm of the trial, the surgeon will place a synthetic graft connecting an artery and vein under the skin in an upper extremity.

Arteriovenous Graft (AVG)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age greater than 65 years old.
• On hemodialysis through a tunneled dialysis catheter.
• In the surgeon's opinion, both a fistula and a graft can be reasonably attempted, based on the patient's anatomy.

You may not qualify if:

• Unable to provide informed consent.
• Unable to be medically cleared for surgery
• Does not wish to have surgery.
• Does not wish to be randomized.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Arteriovenous Fistula

Interventions

Arteriovenous Shunt, Surgical

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Study Officials

• Theodore Yuo, MD MSc

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study will provide preliminary data and possibly demonstrate feasibility of a large scale randomized controlled trial comparing AVF and AVG in elderly patients (defined as patients over 65 years of age) receiving hemodialysis through a TDC.

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 12, 2018
• Study Start: September 14, 2018
• Primary Completion: August 7, 2023
• Study Completion: August 7, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)