End Stage Renal Disease (ESRD)
Conditions
Keywords
dialysis, HeRO graft, catheter, chronic renal failure, end stage renal disease, renal insufficiency
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.
Interventions
None listed
Sponsors
CryoLife, Inc.
Merit Medical Systems, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 1 year | Compare mortality rate between study arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HeRO Graft patients who are evaluated and receive a HeRO graft implant for hemodialysis | 16 |
| Control control group of non-HeRO patients who are evaluated but do not receive a HeRO graft for any reason | 17 |
| Total | 33 |
Baseline characteristics
| Characteristic | Total | HeRO Graft | Control |
|---|---|---|---|
| Age, Continuous | 60.00 years STANDARD_DEVIATION 11.38 | 56.69 years STANDARD_DEVIATION 11.08 | 63.12 years STANDARD_DEVIATION 11.49 |
| Region of Enrollment United States | 33 participants | 16 participants | 17 participants |
| Sex: Female, Male Female | 21 Participants | 9 Participants | 12 Participants |
| Sex: Female, Male Male | 12 Participants | 7 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 17 |
| serious Total, serious adverse events | 16 / 16 | 15 / 17 |
Outcome results
Primary
Mortality
Compare mortality rate between study arms
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HeRO Graft | Mortality | 18.8 percentage of participants who died |
| Control | Mortality | 29.4 percentage of participants who died |
p-value: 0.48Chi-squared
Secondary
Hospitalization Rate (Percentage of Participants Who Were Hospitalized at Least Once While on Study)
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.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HeRO Graft | Hospitalization Rate (Percentage of Participants Who Were Hospitalized at Least Once While on Study) | 62.5 Percentage of patients |
| Control | Hospitalization Rate (Percentage of Participants Who Were Hospitalized at Least Once While on Study) | 64.7 Percentage of patients |
p-value: 0.9Chi-squared
Secondary
Infection Rate (Percentage of Participants With at Least One Infection)
Compare incidence of infection between study arms
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HeRO Graft | Infection Rate (Percentage of Participants With at Least One Infection) | 25.0 Percentage of Patients |
| Control | Infection Rate (Percentage of Participants With at Least One Infection) | 64.7 Percentage of Patients |
p-value: 0.02Chi-squared
Secondary
Intervention Rate (Percentage of Participants Who Required at Least One Intervention While on Study)
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.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HeRO Graft | Intervention Rate (Percentage of Participants Who Required at Least One Intervention While on Study) | 93.8 percentage of participants |
| Control | Intervention Rate (Percentage of Participants Who Required at Least One Intervention While on Study) | 64.7 percentage of participants |
p-value: 0.04Chi-squared
Secondary
Quality of Life
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).
Time frame: 1 year
Population: The number of completed tests varied by time point and study group. The number of completed tests for Test 1, Test 2, Test 3, and Test 4 was 14, 13, 10, and 8 for the HeRO Graft group and 17, 13, 7, and 4 for the Control group, respectively. Only completed tests were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HeRO Graft | Quality of Life | Test 1 (Baseline) | 58.06 units on a scale | Standard Deviation 25.49 |
| HeRO Graft | Quality of Life | Test 2 (3 Months) | 56.30 units on a scale | Standard Deviation 23.78 |
| HeRO Graft | Quality of Life | Test 3 (6 Months) | 58.44 units on a scale | Standard Deviation 22.08 |
| HeRO Graft | Quality of Life | Test 4 (12 Months) | 60.41 units on a scale | Standard Deviation 18.06 |
| Control | Quality of Life | Test 4 (12 Months) | 20.14 units on a scale | Standard Deviation 4.67 |
| Control | Quality of Life | Test 1 (Baseline) | 51.30 units on a scale | Standard Deviation 28.78 |
| Control | Quality of Life | Test 3 (6 Months) | 53.53 units on a scale | Standard Deviation 23.49 |
| Control | Quality of Life | Test 2 (3 Months) | 55.22 units on a scale | Standard Deviation 22.4 |
p-value: 0.49t-test, 2 sided
p-value: 0.91t-test, 2 sided
p-value: 0.67t-test, 2 sided
p-value: <0.001t-test, 2 sided