HeRO Graft Compared to Permanent Catheters for End Stage Renal Disease (ESRD) Patients Receiving Hemodialysis

Completed

Conditions: End Stage Renal Disease (ESRD)

Registration Number: NCT01343251

Lead Sponsor: Merit Medical Systems, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 33

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	1 year	Compare mortality rate between study arms

Secondary Outcome Measures

Name	Time	Method
Infection Rate (Percentage of Participants With at Least One Infection)	1 year	Compare incidence of infection between study arms
Quality of Life	1 year	Compare the RAND Short Form (SF)-36 Health Survey, Total Test Scores at baseline, 3, 6, and 12 months between study arms. Total test scores range on a scale from 0-100, with the lower the score equating to more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. The total score is calculated using a methodology described by the RAND Corporation, which assigns a recoded value to each survey item. Recoded items are averaged amongst scales and the total score is an average of the eight sections. (http://www.rand.org/content/dam/rand/www/external/health/surveys_tools/mos/mos_core_36item_scoring.pdf).
Intervention Rate (Percentage of Participants Who Required at Least One Intervention While on Study)	1 year	Compare vascular intervention rates between study arms. The vascular interventions which were included were: Angioplasty, Thrombectomy, Arteriovenous (AV) Fistulogram/Diagnostic Angiogram, Banding, Access Removal, Access Exchange, Access Revision, Creation of New Access, and any combination of these interventions which were performed simultaneously.
Hospitalization Rate (Percentage of Participants Who Were Hospitalized at Least Once While on Study)	1 year	Compare incidence of hospitalization (for any reason) between study arms. Reasons for hospitalizations included: infection, cardiac problems, bleeding, vascular access thrombosis, fall (injury), hematuria, fluid overload, peripheral neuropathy, pulmonary embolism, edema, and shortness of breath.