Access Flow Based Intervention for Management of Arteriovenous Hemodialysis Access Dysfunction.

NCT02628119 | Unknown DMC

• 1 other identifier: 2151 040
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Hemodialysis (HD) vascular access dysfunction is a huge clinical problem which results in significant clinical morbidity in patients with End Stage Renal Disease (ESRD), causing a severe economic burden on any health care system. Arteriovenous (A-V) dialysis accesses are the preferred form of permanent dialysis access as compared to central venous catheters (CVC) . One of the reasons for CVC use is poor long term patency rates of A-V access. Arteriovenous Grafts (AVG) have a primary patency rates of just under 50% at 12 months and around 33% at 18 months. Native arteriovenous fistula (AVF) are slightly better with primary patency rates of around 60 percent at one year and 51 percent at 2 years. The most common cause for AVF and AVG dysfunction is stenosis development due to neointimal hyperplasia (NIH) within the circuit leading to access thrombosis. Percutaneous transluminal angioplasty (PTA) is the current standard of treatment for these lesions. Despite being the treatment of choice for these lesions patency rates after PTA continue to be dismal. One of the problems with poor long term outcomes after successful intervention is how you assess immediate intervention success. Successful angioplasty is defined by Dialysis Outcome Quality Initiative (DOQI) guidelines as one where only less than 30% residual stenosis remains at the end of intervention. Unfortunately angiographic images post angioplasty correlate poorly with improvement of access flows through the arteriovenous circuit. There are two main problems with these practice standards. First, they are based on a 2-dimensional angiographic view of the lesion which may be misleading. Secondly, this assessment of recoil is very subjective and not base on objective data. Access flow monitoring can now be performed intra-procedurally with thermal dilution technique. Its benefit was shown in a small pilot study. To date there have not been any randomized controlled trials to assess the benefit of such an approach where intervention is based on improvements in access flow at the time of intervention. We hypothesize that such an approach will improve outcomes after interventions related to access dysfunction. This may also identify the right scenarios in which stent placement may benefit thus improving outcomes after stent placement as well.

Conditions

Hemodialysis Arteriovenous Fistula Maturation Failure

Keywords

Hemodialysis; vascular access; access flow

Outcome Measures

Primary Outcomes (1)

• Primary un-assisted patency

  The AVF is still being used for dialysis with a minimum blood pump speed of 300ml/min and no additional procedures have been done to maintain patency

  6 months

Secondary Outcomes (2)

• Secondary or assisted patency

  6 months

• Number of procedures required in each group to maintain patency

  6 months

Study Arms (2)

Intra-procedural access flow

EXPERIMENTAL

Management of access dysfunction based on intra-procedure access flow monitoring. Criteria for target access flow: Within 90% of baseline access flow if known 180% increase from pre-intervention flow if access flow not known 600ml/min for thrombosed grafts and 500 ml/min for thrombosed arteriovenous fistula in case baseline access flow not known

Procedure: Intra-procedural access flow

Standard Angioplasty

ACTIVE COMPARATOR

Intervention based on current standards of care i.e. 2 dimensional angiographic views.

Procedure: Standard Angioplasty

Interventions

Intra-procedural access flow PROCEDURE

Intra-procedure access flow technique: Room temperature saline is injected into the vascular access blood stream during angioplasty via ReoCath(tm) 6 French antegrade or retrograde flow catheters. When the saline is injected into the access, an injection thermistor located close to the proximal end of the catheter records the temperature of the injected saline. A second thermistor located close to the distal tip of the catheter then records the thermodilution within the access and the HVT100 endovascular flow meter calculates and displays intragraft blood flow in ml/min.

Intra-procedural access flow

Standard Angioplasty PROCEDURE

Intervention based on 2 Dimensional fluoroscopy views

Standard Angioplasty

Eligibility Criteria

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

You may qualify if:

• Age \>18 years
• Patients with ESRD and access dysfunction secondary to stenosis anywhere in the AVF.

You may not qualify if:

• Patients on anti-coagulation and those with bleeding disorders
• Life expectancy less than 12 months.
• Documented severe contrast allergy.
• Inability to come for timely and adequate follow up.
• Patients undergoing transplantation work up and expected to be transplanted within 6 months.
• AVG with access dysfunction developing within 30 days of surgery.
• AVF with early fistula failure.
• Recurrence of stenosis within 3 months of previous intervention.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital & Research Center

Riyadh, 11211, Saudi Arabia

RECRUITING

Related Publications (8)

• Foley RN, Collins AJ. The USRDS: what you need to know about what it can and can't tell us about ESRD. Clin J Am Soc Nephrol. 2013 May;8(5):845-51. doi: 10.2215/CJN.06840712. Epub 2012 Nov 2.

  PMID: 23124788 BACKGROUND

• Feldman HI, Kobrin S, Wasserstein A. Hemodialysis vascular access morbidity. J Am Soc Nephrol. 1996 Apr;7(4):523-35. doi: 10.1681/ASN.V74523.

  PMID: 8724885 BACKGROUND

• Beathard GA. Percutaneous transvenous angioplasty in the treatment of vascular access stenosis. Kidney Int. 1992 Dec;42(6):1390-7. doi: 10.1038/ki.1992.431.

  PMID: 1474770 BACKGROUND

• Glanz S, Gordon DH, Butt KM, Hong J, Lipkowitz GS. The role of percutaneous angioplasty in the management of chronic hemodialysis fistulas. Ann Surg. 1987 Dec;206(6):777-81. doi: 10.1097/00000658-198712000-00015.

  PMID: 2961315 BACKGROUND

• Ahya SN, Windus DW, Vesely TM. Flow in hemodialysis grafts after angioplasty: Do radiologic criteria predict success? Kidney Int. 2001 May;59(5):1974-8. doi: 10.1046/j.1523-1755.2001.0590051974.x.

  PMID: 11318971 BACKGROUND

• Maursetter L, Yevzlin AS. The use of intravascular ultrasound to assist angiography in diagnosis and management of hemodialysis access. Semin Dial. 2011 Jan-Feb;24(1):89-91. doi: 10.1111/j.1525-139X.2011.00840.x.

  PMID: 21338398 BACKGROUND

• Krivitski NM, MacGibbon D, Gleed RD, Dobson A. Accuracy of dilution techniques for access flow measurement during hemodialysis. Am J Kidney Dis. 1998 Mar;31(3):502-8. doi: 10.1053/ajkd.1998.v31.pm9506688.

  PMID: 9506688 BACKGROUND

• Vesely TM, Gherardini D, Gleed RD, Kislukhin V, Krivitski NM. Use of a catheter-based system to measure blood flow in hemodialysis grafts during angioplasty procedures. J Vasc Interv Radiol. 2002 Apr;13(4):371-8. doi: 10.1016/s1051-0443(07)61739-4.

  PMID: 11932367 BACKGROUND

Study Officials

• Naveed U Haq, MD, FASN

  King Faisal Specialist Hospital & Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naveed U Haq, MD, FASN

CONTACT

+966 11 4427492; nulhaq@kfshrc.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Interventional Nephrology and Dialysis Access Program

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: December 11, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 4, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

SA (1)