Prospective Analysis of Hemodialysis Reliable Outflow (HeRO) Vascular Access Graft vs. Cuffed Catheter Access in Hemodialysis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- End Stage Renal Disease (ESRD)
- Sponsor
- Merit Medical Systems, Inc.
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Mortality
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The main objective of this research study was to compare the following outcomes between patients with a Hemodialysis Reliable Outflow (HeRO) Graft and patients with a cuffed catheter for dialysis access over one year: quality of life and incidence of bacteremia, vascular interventions, hospitalizations, and death.
Detailed Description
All eligible participants who provided informed consent were included in the study. Participants who refused HeRO Graft implantation, or did not have the HeRO Graft implanted for any other reason, were followed in the control group. Several patients did not receive the HeRO graft due to anatomical challenges and failure to complete both steps of the two-stage implant procedure. All consented participants who had an implanted HeRO Graft were followed in the study group. All participants were followed until the study end, withdrawal, loss to follow-up, or death. The analysis included only HeRO Graft patients and control patients who were not lost to follow-up; patients who were lost to follow-up, before data collection, were excluded from analysis. After obtaining Institutional Review Board (IRB) approval, baseline demographic and clinical data was collected. Following surgery, implant procedure data was collected on study participants who received HeRO Grafts. HeRO Grafts were placed using a 2-step process with initial placement of the ePTFE portion, followed by completion of the graft by placement of the venous outflow component. Following enrollment, outcomes of interest were collected at follow-up visits scheduled weekly for 4 weeks, bi-weekly for 3 months, and monthly to 1 year, for a total of 18 follow-up visits. Study coordinators documented post-operative complications, incidence of thrombosis, hospitalizations, infection incidents, and deaths at each follow-up. Quality of life data were also collected from all participants using the RAND Corporation's Short Form (36) (SF-36) Health Survey. This survey was completed at enrollment and again at 3 months, 6 months, and 12 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •ESRD patients requiring hemodialysis
- •Age ≥ 18 years old
- •Able to give informed consent
- •Able to participate in quality of life survey
- •All patients who are not candidate for arteriovenous fistula (AVF) or arteriovenous graft (AVG)
- •Life expectancy 2 years or greater
- •Willing and able to participate with follow-up examinations
Exclusion Criteria
- •Pregnant or breastfeeding females
- •Disorder that compromises the ability to give informed consent and/or comply with the study procedures
- •Any medical condition that in the opinion of the investigator may pose a safety risk to a subject in the study or which may interfere with the study participation
Outcomes
Primary Outcomes
Mortality
Time Frame: 1 year
Compare mortality rate between study arms
Secondary Outcomes
- Infection Rate (Percentage of Participants With at Least One Infection)(1 year)
- Quality of Life(1 year)
- Intervention Rate (Percentage of Participants Who Required at Least One Intervention While on Study)(1 year)
- Hospitalization Rate (Percentage of Participants Who Were Hospitalized at Least Once While on Study)(1 year)