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

NCT01343251 | Completed Results

• 1 other identifier: HeRO-1
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease (ESRD)

Keywords

dialysis; HeRO graft; catheter; chronic renal failure; end stage renal disease; renal insufficiency

Outcome Measures

Primary Outcomes (1)

• Mortality

  Compare mortality rate between study arms

  1 year

Secondary Outcomes (4)

• Infection Rate (Percentage of Participants With at Least One Infection)

  1 year

• Quality of Life

  1 year

• Intervention Rate (Percentage of Participants Who Required at Least One Intervention While on Study)

  1 year

• Hospitalization Rate (Percentage of Participants Who Were Hospitalized at Least Once While on Study)

  1 year

Study Arms (2)

HeRO Graft

patients who are evaluated and receive a HeRO Graft implant for hemodialysis

Control

control group of non-HeRO patients who are evaluated but do not receive a HeRO Graft for any reason

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merit Medical Systems, Inc.: lead
• CryoLife, Inc.: collaborator

Study Sites (1)

St. Clair Specialty Physicians

Detroit, Michigan, 48236, United States

Location

Related Publications (15)

• Ethier J, Mendelssohn DC, Elder SJ, Hasegawa T, Akizawa T, Akiba T, Canaud BJ, Pisoni RL. Vascular access use and outcomes: an international perspective from the Dialysis Outcomes and Practice Patterns Study. Nephrol Dial Transplant. 2008 Oct;23(10):3219-26. doi: 10.1093/ndt/gfn261. Epub 2008 May 29.

  PMID: 18511606 BACKGROUND

• Foley RN, Chen SC, Collins AJ. Hemodialysis access at initiation in the United States, 2005 to 2007: still "catheter first". Hemodial Int. 2009 Oct;13(4):533-42. doi: 10.1111/j.1542-4758.2009.00396.x. Epub 2009 Sep 16.

  PMID: 19758304 BACKGROUND

• Mokrzycki MH, Zhang M, Cohen H, Golestaneh L, Laut JM, Rosenberg SO. Tunnelled haemodialysis catheter bacteraemia: risk factors for bacteraemia recurrence, infectious complications and mortality. Nephrol Dial Transplant. 2006 Apr;21(4):1024-31. doi: 10.1093/ndt/gfi104. Epub 2006 Jan 31.

  PMID: 16449293 BACKGROUND

• Katzman HE, McLafferty RB, Ross JR, Glickman MH, Peden EK, Lawson JH. Initial experience and outcome of a new hemodialysis access device for catheter-dependent patients. J Vasc Surg. 2009 Sep;50(3):600-7, 607.e1. doi: 10.1016/j.jvs.2009.04.014. Epub 2009 Jul 22.

  PMID: 19628360 BACKGROUND

• Hakim RM, Himmelfarb J. Hemodialysis access failure: a call to action--revisited. Kidney Int. 2009 Nov;76(10):1040-8. doi: 10.1038/ki.2009.318. Epub 2009 Aug 26.

  PMID: 19710629 BACKGROUND

• Pisoni RL, Young EW, Dykstra DM, Greenwood RN, Hecking E, Gillespie B, Wolfe RA, Goodkin DA, Held PJ. Vascular access use in Europe and the United States: results from the DOPPS. Kidney Int. 2002 Jan;61(1):305-16. doi: 10.1046/j.1523-1755.2002.00117.x.

  PMID: 11786113 BACKGROUND

• Surratt RS, Picus D, Hicks ME, Darcy MD, Kleinhoffer M, Jendrisak M. The importance of preoperative evaluation of the subclavian vein in dialysis access planning. AJR Am J Roentgenol. 1991 Mar;156(3):623-5. doi: 10.2214/ajr.156.3.1781814.

  PMID: 1781814 BACKGROUND

• Bohlke M, Uliano G, Barcellos FC. Hemodialysis catheter-related infection: prophylaxis, diagnosis and treatment. J Vasc Access. 2015 Sep-Oct;16(5):347-55. doi: 10.5301/jva.5000368. Epub 2015 Apr 20.

  PMID: 25907773 BACKGROUND

• Yoon WJ, Lorelli DR. Avoiding the use of a femoral bridging catheter using a two-stage Hemodialysis Reliable Outflow (HeRO) graft implantation technique. J Vasc Access. 2015 May-Jun;16(3):189-94. doi: 10.5301/jva.5000325. Epub 2015 Jan 20.

  PMID: 25613143 BACKGROUND

• Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

  PMID: 1593914 BACKGROUND

• Gage SM, Katzman HE, Ross JR, Hohmann SE, Sharpe CA, Butterly DW, Lawson JH. Multi-center experience of 164 consecutive Hemodialysis Reliable Outflow [HeRO] graft implants for hemodialysis treatment. Eur J Vasc Endovasc Surg. 2012 Jul;44(1):93-9. doi: 10.1016/j.ejvs.2012.04.011. Epub 2012 May 12.

  PMID: 22580402 BACKGROUND

• Tonnessen BH, Money SR. Embracing the fistula first national vascular access improvement initiative. J Vasc Surg. 2005 Sep;42(3):585-6. doi: 10.1016/j.jvs.2005.05.030. No abstract available.

  PMID: 16171614 BACKGROUND

• Berwick DM, Nolan TW, Whittington J. The triple aim: care, health, and cost. Health Aff (Millwood). 2008 May-Jun;27(3):759-69. doi: 10.1377/hlthaff.27.3.759.

  PMID: 18474969 BACKGROUND

• Dageforde LA, Bream PR, Moore DE. Hemodialysis Reliable Outflow (HeRO) device in end-stage dialysis access: a decision analysis model. J Surg Res. 2012 Sep;177(1):165-71. doi: 10.1016/j.jss.2012.04.041. Epub 2012 May 9.

  PMID: 22608835 BACKGROUND

• Ware JE, Kosinski M, Gandek. SF-36 Health Survey Manual & Interpretation Guide. Lincoln RI, Quality Metric Incorporated, 2000, pp. 10-14

  BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Target sample size (statistical power) was not achieved. Catheter reduction and fistula first policies limited recruitment. Additionally, study patients were not blind to exposure and this knowledge may have had an impact on QoL measurement.

Results Point of Contact

• Title: Dr. Robert Provenzano
• Organization: St John Hospital and Medical Center

Rprovenzano@scsp.net

313-886-8787

Study Officials

• Robert Provenzano, MD

  St. Clair Specialty Physicians

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: April 28, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 8, 2017
• Results First Posted: March 14, 2016

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)