N/A N=33

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

End Stage Renal Disease (ESRD)

Bottom Line

View on ClinicalTrials.gov: NCT01343251 ↗

Enrolled (actual)

Serious AEs

93.9%

Results posted

Mar 2016

Primary outcome: Primary: Mortality — 18.8; 29.4 percentage of participants who died — p=0.48

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merit Medical Systems, Inc.
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Mortality	18.8; 29.4	0.48
SECONDARY Infection Rate (Percentage of Participants With at Least One Infection)	25.0; 64.7	0.02 sig
SECONDARY Quality of Life	58.06; 51.30; 56.30; 55.22; 58.44; 53.53	0.49
SECONDARY Intervention Rate (Percentage of Participants Who Required at Least One Intervention While on Study)	93.8; 64.7	0.04 sig
SECONDARY Hospitalization Rate (Percentage of Participants Who Were Hospitalized at Least Once While on Study)	62.5; 64.7	0.90

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.

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

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Data sourced from ClinicalTrials.gov (NCT01343251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.