ACCESS HD: Comparing Catheters to Fistulas in Elderly Patients Starting Hemodialysis

NCT02675569 | Unknown

• 1 other identifier: REB14-1670
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 13

Brief Summary

This randomized controlled trial (RCT) is multi-center, parallel-arm, and open label. It will test the feasibility and safety of randomizing elderly patients with end-stage kidney failure starting hemodialysis with a tunneled/non-tunneled catheter to one of the following vascular access strategies: (a) attempt at fistula creation (intervention), or (b) continued use of a catheter (comparator). A total number of 100 participants will be enrolled in vanguard phase of the RCT. The rationale for this trial includes: (1) the importance of the intervention question related to the choice of vascular access for patients treated with hemodialysis; (2) lack of evidence from clinical trials for decision-making in this area (only observational studies are available); (3) existing studies which suggest that fistula use is associated with better patient outcomes are very prone to selection bias; (4) need for a clinical trial comparing the impact of the two most frequently chosen strategies for vascular access (catheter and fistula) in the hemodialysis population; and (5) a feasible and safe trial design. The results obtained from this vanguard phase of the RCT will determine the feasibility and safety of conducting a large RCT, which will be powered for the primary outcome of days spent in hospital.

Conditions

End-stage Kidney Failure

Keywords

Vascular access; Hemodialysis; Kidney failure; Catheter; Fistula

Outcome Measures

Primary Outcomes (2)

• Feasibility; proportion of eligible people who are randomized (at least 25%)

  42 months

• Feasibility; proportion of those randomized to the intervention arm receiving a fistula attempt within 90 days of randomization (at least 80%)

  42 months

Secondary Outcomes (7)

• Descriptive; reasons for exclusion of all screened participants (feasibility)

  42 months

• Descriptive; reasons that people decline to participate (feasibility)

  42 months

• Descriptive; reasons people are considered ineligible for a fistula attempt (feasibility)

  42 months

• Descriptive; reasons for delayed access to fistula surgery (feasibility)

  42 months

• Safety; expected procedure-related outcomes for both catheter and fistula treatment strategies that occur within 7 days of the execution of any access related intervention

  7 days

Study Arms (2)

Catheter

ACTIVE COMPARATOR

Catheter is a method of vascular access for hemodialysis. It consists of a long, thin plastic tube and may be either tunnelled or non-tunnelled.

Procedure: Catheter

Fistula

EXPERIMENTAL

Fistula is a type of vascular access strategy for hemodialysis in which a direct connection of an artery to a vein is created. It is intended to provide an access with good blood flow that can last for decades.

Procedure: Fistula

Interventions

Catheter PROCEDURE

A method of vascular access for hemodialysis that all participants will have in place prior to randomization.

Catheter

Fistula PROCEDURE

A type of vascular access strategy for hemodialysis which involves connecting the artery and the veins in the participant's arm.

Fistula

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients age ≥ 55; (AUS sites : adult patients age ≥ 65);
• a). Started hemodialysis using a tunnelled, or non-tunnelled catheter for vascular access AND ≤ 1 previously unsuccessful fistula attempt; OR b).Changing over from peritoneal dialysis AND no functioning arteriovenous fistula available at HD start;
• Treated with hemodialysis for 365 days or less at the time of consent (374 days or less at the time of randomization);
• Clinically and cognitively stable (able to provide consent within 365 days of hemodialysis start);
• Hemodialysis is the intended modality of treatment;
• End-stage (permanent) kidney failure unlikely to recover kidney function according to the attending nephrologist;
• Eligible for a fistula attempt as determined by the local multidisciplinary access team;
• Planning to remain in the current dialysis center/service for at least 6 months;

You may not qualify if:

• Started hemodialysis with a fistula or have a patent fistula already in place or had \>1 unsuccessful attempt; (AUS sites: or previously functioning fistula no longer working);
• Has had a prior arteriovenous graft creation;
• Imminent transplant planned (within 6 months);
• Metastatic malignancy or other condition associated with a life expectancy of less than 6 months, in the opinion of the attending nephrologist;

Sponsors & Collaborators

• University of Calgary: lead
• Applied Health Research Centre: collaborator
• The George Institute: collaborator

Study Sites (13)

The Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

NOT YET RECRUITING

Illawarra Shoalhaven Local Health District (ISLHD)

Wollongong, New South Wales, 2500, Australia

RECRUITING

Sunshine Coast Hospital and Health Service (SCHHS)

Birtinya, Queensland, 4575, Australia

RECRUITING

University of Calgary

Calgary, Alberta, T2R 0X7, Canada

RECRUITING

University of Alberta

Edmonton, Alberta, T6G 2G3, Canada

ACTIVE NOT RECRUITING

University of Manitoba

Winnipeg, Manitoba, R3A 1R9, Canada

COMPLETED

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

COMPLETED

St. Joseph's Hospital

Hamilton, Ontario, L8N 4A6, Canada

WITHDRAWN

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

WITHDRAWN

The Ottawa Hospital

Ottawa, Ontario, K1H 7W9, Canada

RECRUITING

Humber River Hospital

Toronto, Ontario, M3M 0B2, Canada

COMPLETED

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Related Publications (14)

• Lee H, Manns B, Taub K, Ghali WA, Dean S, Johnson D, Donaldson C. Cost analysis of ongoing care of patients with end-stage renal disease: the impact of dialysis modality and dialysis access. Am J Kidney Dis. 2002 Sep;40(3):611-22. doi: 10.1053/ajkd.2002.34924.

  PMID: 12200814 BACKGROUND

• Jindal K, Chan CT, Deziel C, Hirsch D, Soroka SD, Tonelli M, Culleton BF; Canadian Society of Nephrology Committee for Clinical Practice Guidelines. Hemodialysis clinical practice guidelines for the Canadian Society of Nephrology. J Am Soc Nephrol. 2006 Mar;17(3 Suppl 1):S1-27. doi: 10.1681/ASN.2005121372. No abstract available.

  PMID: 16497879 BACKGROUND

• Ravani P, Palmer SC, Oliver MJ, Quinn RR, MacRae JM, Tai DJ, Pannu NI, Thomas C, Hemmelgarn BR, Craig JC, Manns B, Tonelli M, Strippoli GF, James MT. Associations between hemodialysis access type and clinical outcomes: a systematic review. J Am Soc Nephrol. 2013 Feb;24(3):465-73. doi: 10.1681/ASN.2012070643. Epub 2013 Feb 21.

  PMID: 23431075 BACKGROUND

• Quinn RR, Laupacis A, Hux JE, Oliver MJ, Austin PC. Predicting the risk of 1-year mortality in incident dialysis patients: accounting for case-mix severity in studies using administrative data. Med Care. 2011 Mar;49(3):257-66. doi: 10.1097/MLR.0b013e318202aa0b.

  PMID: 21301370 BACKGROUND

• Tennankore KK, Soroka SD, Kiberd BA. The impact of an "acute dialysis start" on the mortality attributed to the use of central venous catheters: a retrospective cohort study. BMC Nephrol. 2012 Jul 30;13:72. doi: 10.1186/1471-2369-13-72.

  PMID: 22846341 BACKGROUND

• Mazonakis E, Stirling C, Booth KL, McClenahan J, Heron N, Geddes CC. The influence of comorbidity on the risk of access-related bacteremia in chronic hemodialysis patients. Hemodial Int. 2009 Jan;13(1):6-10. doi: 10.1111/j.1542-4758.2009.00327.x.

  PMID: 19210271 BACKGROUND

• Lok CE, Allon M, Moist L, Oliver MJ, Shah H, Zimmerman D. Risk equation determining unsuccessful cannulation events and failure to maturation in arteriovenous fistulas (REDUCE FTM I). J Am Soc Nephrol. 2006 Nov;17(11):3204-12. doi: 10.1681/ASN.2006030190. Epub 2006 Sep 20.

  PMID: 16988062 BACKGROUND

• Quinn RR, Lamping DL, Lok CE, Meyer RA, Hiller JA, Lee J, Richardson EP, Kiss A, Oliver MJ. The Vascular Access Questionnaire: assessing patient-reported views of vascular access. J Vasc Access. 2008 Apr-Jun;9(2):122-8.

  PMID: 18609528 BACKGROUND

• Oliver MJ, Verrelli M, Zacharias JM, Blake PG, Garg AX, Johnson JF, Pandeya S, Perl J, Kiss AJ, Quinn RR. Choosing peritoneal dialysis reduces the risk of invasive access interventions. Nephrol Dial Transplant. 2012 Feb;27(2):810-6. doi: 10.1093/ndt/gfr289. Epub 2011 Jun 21.

  PMID: 21693682 BACKGROUND

• Tordoir J, Canaud B, Haage P, Konner K, Basci A, Fouque D, Kooman J, Martin-Malo A, Pedrini L, Pizzarelli F, Tattersall J, Vennegoor M, Wanner C, ter Wee P, Vanholder R. EBPG on Vascular Access. Nephrol Dial Transplant. 2007 May;22 Suppl 2:ii88-117. doi: 10.1093/ndt/gfm021. No abstract available.

  PMID: 17507428 BACKGROUND

• Casey JR, Hanson CS, Winkelmayer WC, Craig JC, Palmer S, Strippoli GF, Tong A. Patients' perspectives on hemodialysis vascular access: a systematic review of qualitative studies. Am J Kidney Dis. 2014 Dec;64(6):937-53. doi: 10.1053/j.ajkd.2014.06.024. Epub 2014 Aug 10.

  PMID: 25115617 BACKGROUND

• Detry MA, Lewis RJ. The intention-to-treat principle: how to assess the true effect of choosing a medical treatment. JAMA. 2014 Jul 2;312(1):85-6. doi: 10.1001/jama.2014.7523. No abstract available.

  PMID: 25058221 BACKGROUND

• Murea M, James KM, Russell GB, Byrum GV 3rd, Yates JE, Tuttle NS, Bleyer AJ, Burkart JM, Freedman BI. Risk of catheter-related bloodstream infection in elderly patients on hemodialysis. Clin J Am Soc Nephrol. 2014 Apr;9(4):764-70. doi: 10.2215/CJN.07710713. Epub 2014 Mar 20.

  PMID: 24651074 BACKGROUND

• Quinn R, Ravani P; ACCESS HD Investigators. ACCESS HD pilot: A randomised feasibility trial Comparing Catheters with fistulas in Elderly patientS Starting haemodialysis. BMJ Open. 2016 Nov 24;6(11):e013081. doi: 10.1136/bmjopen-2016-013081.

  PMID: 27884849 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Renal Insufficiency; Fistula

Interventions

Catheters; Portacaval Shunt, Surgical

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Study Officials

• Rob Quinn, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Pietro Ravani, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sorcha Mulligan

CONTACT

416-360-4000; sorcha.mulligan@unityhealth.to

Sharon Gulewich

CONTACT

403-955-6387; Sharon.Gulewich@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrologist and Associate Professor

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: February 5, 2016
• Study Start: May 1, 2016
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); CA (10)