End stage renal disease (ESRD), haemodialysis Urological and Genital Diseases Haemodialysis
Conditions
Interventions
For this study the trial intervention will be the surgical creation, by a qualified participating surgeon, and guideline recommended follow-up management of either an AVF or AV-graft in the upper arm
Sponsors
Toronto General Hospital Research Institute (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients requiring chronic HD who have already failed a forearm permanent access (AVF or AV-graft) or who require another permanent VA for HD 2. Considered suitable for an upper arm AVF 3. Aged greater than 18 years old, either sex 4. Presence of irreversible chronic renal failure requiring haemodialyisis 5. Three times weekly dialysis 6. Must have vessels deemed suitable for creation of an AVF according to the surgeon and must include at least two of the following features: 6.1. Visible length of at least 4 - 6 cm on physical exam, dependent on patient size (with or without augmentation) 6.2. Palpable length of at least 4 - 6 cm on physical exam, dependent on patient size (with or without augmentation) 7. Straight vessel segment Added as of 12/03/2010: The eligibility criteria of the CIHR-funded pilot study includes the following: 8. Inclusion of subjects whose forearm is not a viable site for a first access creation therefore the "first" access is an upper arm access meaning the non-viable forearm site would be considered a "failed" access site for the purposes of the study 9. Inclusion of subjects who are eligible and meet the inclusion/exclusion criteria but refuse the randomisation process of the study 10. Inclusion of subjects that are deemed eligible for study participation by the attending nephrologists or investigator and meet all inclusion/exclusion criteria as per the protocol however the surgeon refuses patient randomisation 11. Inclusion of subjects who are deemed eligible by the attending nephrologists or investigator and surgeon but decline having any access created and continue to use a catheter for haemodialysis treatment *note that subjects enrolled into the study who meet the eligibility criteria #9 through #12 will be followed as "non-randomised" study subjects
Exclusion criteria
Exclusion criteria: 1. Acute renal failure, likely to be reversible with recovery of renal function 2. Involvement in another interventional access study 3. Expected life expectancy less than six months (e.g. due to active malignancy; serious comorbidity such as hepatic failure) 4. Patients who have not yet initiated dialysis 5. Allergies to contrast Added as of 12/03/2010: The eligibility criteria of the CIHR-funded pilot study includes the following: 6. Exclusion of patients receiving more than 4 times per week haemodialysis treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current information as of 01/07/2010: The complication-free vascular access days over 18 months from the date of access creation in patients who receive an upper arm VA after a failed forearm access (fistula). A complication includes any of the following 1. VA related: 1.1. Serious event (thrombosis, radiological or surgical intervention to facilitate or maintain patency, infection/sepsis, mortality (e.g. AVF rupture and exsanguinations) 1.2. VA related bleeding 1.3. VA-related hospitalisation 2. Non-VA related: 2.1. Death from any cause 2.2. Cardiac event 2.3. Cerebrovascular event 2.4. Congestive heart failure Previous information (prior to 01/07/2010): The time to first serious vascular event in patients who receive an upper arm arteriovenous fistula compared with an upper arm AV-graft, after a failed forearm access. Primary and secondary endpoints will be measured on an ongoing basis during the 18 month follow-up phase. Visits to assess for these endpoints will be conducted on a weekly basis. An analysis of all documented endpoints will occur following the 18 month follow-up phase. Added as of 12/03/2010: While the true VA ?cumulative patency? would be ideal, it is not feasible as many accesses can remain patent for greater than 5 years. This would place a burden on resources and limit the ability to conduct other clinical studies in the HD population. Therefore, the primary outcome was changed in the CIHR-funded trial to: The complication-free vascular access days over 18 months from the date of access creation in patients who receive an upper arm VA after a failed forearm access (fistula). A complication includes any of the following 1. VA related: 1.1. Serious event (thrombosis, radiological or surgical intervention to facilitate or maintain patency, infection/sepsis, mortality (e.g. AVF rupture and exsanguinations) 1.2. VA related bleeding 1.3. VA-related hospitalisation 2. Non-VA related: 2.1. Death from any cause 2.2. Cardiac event 2.3. Cerebrov | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Primary patency rates 2. The rates and proportion of interventions required to maintain patency. Rates will be expressed as number of radiological and surgical interventions per access, per access-year, per 1000 access days. This variety will allow comparison of results in the literature. 3. Complication rates: 3.1. Catheter use, its duration (CVC days), and associated complications (such as bleeding, sepsis, hospitalisations) 3.2. Complications directly related to access e.g. infections, central stenosis 3.3. All cause mortality 3.4. Direct VA-related mortality 4. The time to: 4.1. First thrombosis, and 4.2. First radiological or surgical intervention 5. The incidence of primary failure 6. Maximal study cumulative patency: a subset of patients will be followed beyond 18 months until the study has been completed by the last enrolled patient Primary and secondary endpoints will be measured on an ongoing basis during the 18 month follow-up phase. Visits to assess for these endpoints will be conducted on a weekly basis. An analysis of all documented endpoints will occur following the 18 month follow-up phase. | — |
Countries
Canada
Outcome results
None listed