HeRO Graft Compared to Permanent Catheters for End Stage Renal Disease (ESRD) Patients Receiving Hemodialysis
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2011 |
| End Date: | December 2013 |
Prospective Analysis of Hemodialysis Reliable Outflow (HeRO) Vascular Access Graft vs. Cuffed Catheter Access in Hemodialysis
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.
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.
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.
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.
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
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