Clinical trial NCT01343251: HeRO Graft Compared to Permanent Catheters for End Stage Renal Disease (ESRD) Patients Receiving Hemodialysis
Official title: Prospective Analysis of Hemodialysis Reliable Outflow (HeRO) Vascular Access Graft vs. Cuffed Catheter Access in Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease (ESRD)
Keywords: dialysis
HeRO graft
catheter
chronic renal failure
end stage renal disease
renal insufficiency
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: CryoLife, Inc.
First posted: 2011-04-28
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with ESRD requiring permanent cuffed catheters were targeted. Participants who had not exhausted peripheral venous access sites suitable for fistulas and grafts were excluded.

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.

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

Primary outcomes:
measure: Mortality
timeFrame: 1 year
Secondary outcomes:
measure: Infection Rate (Percentage of Participants With at Least One Infection)
timeFrame: 1 year
measure: Quality of Life
timeFrame: 1 year
measure: Intervention Rate (Percentage of Participants Who Required at Least One Intervention While on Study)
timeFrame: 1 year
measure: Hospitalization Rate (Percentage of Participants Who Were Hospitalized at Least Once While on Study)
timeFrame: 1 year
Other outcomes:
Locations:
city: Detroit
country: United States
facility: St. Clair Specialty Physicians
state: Michigan
Study officials:
affiliation: St. Clair Specialty Physicians
name: Robert Provenzano, MD
role: PRINCIPAL_INVESTIGATOR
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