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

End Stage Renal Disease (ESRD) Clinical Trial

Official title:

Prospective Analysis of Hemodialysis Reliable Outflow (HeRO) Vascular Access Graft vs. Cuffed Catheter Access in Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343251
• Other study ID #: HeRO-1
• Status: Completed
• Phase: N/A
• First received: April 20, 2011
• Last updated: February 16, 2016
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: February 2016
• Source: Hemosphere, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• End Stage Renal Disease (ESRD)
• Kidney Diseases
• Kidney Failure, Chronic

Locations

Country	Name	City	State
United States	St. Clair Specialty Physicians	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Hemosphere, Inc.	CryoLife, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

Böhlke 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. — View Citation

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. — View Citation

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. Erratum in: Nephrol Dial Transplant. 2008 Dec;23(12):4088. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2006 Jan 31. — View Citation

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. — View Citation

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. — View Citation

Tonnessen BH, Money SR. Embracing the fistula first national vascular access improvement initiative. J Vasc Surg. 2005 Sep;42(3):585-6. — View Citation

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. — View Citation

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

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Compare mortality rate between study arms	1 year	Yes
Secondary	Infection Rate (Percentage of Participants With at Least One Infection)	Compare incidence of infection between study arms	1 year	Yes
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).	1 year	No
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.	1 year	No
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.	1 year	No