The goal of this clinical trial is to evaluate the health effects of expanded hemodialysis in patients receiving hemodialysis. The main question it aims to answer is:
1\) Does expanded hemodialysis reduce the risk of death from any cause?
Researchers will compare expanded hemodialysis to conventional hemodialysis (the treatment currently used for the majority of patients receiving hemodialysis) to see if expanded hemodialysis works to improve patient outcomes.
Participants will continue to receive their regularly scheduled hemodialysis treatments using either a super high-flux/expanded dialysis filter or a high-flux/conventional dialysis filter. All other aspects of treatments remain the same. No additional tests or visits are required. Data will be obtained using administrative healthcare databases and medical record review (at a subset of participating locations).
Age 60 years or older; or
Age 45 to 59 years with a history of diabetes mellitus (Type 1 or Type 2) regardless of current glycemic status; and
Receiving any form of dialysis regularly for the previous 90 days; and
Currently receiving HD in-centre (main or satellite unit) 3 or more times per week; and
Known or anticipated intolerance to the Nipro Elisio HX dialyzer; or
Planned to receive HDF; or
Planned to receive nocturnal HD; or
Anticipated to discontinue in-centre HD in the next 3 months for any reason (examples: palliation, transplantation, home dialysis, recovery of kidney function, death, others); or
Parallel
Super High-Flux Dialyzer
DeviceA hemodialysis filter (known as a dialyzer) that is currently approved by Health Canada and available for use across Canada. This filter has larger pores than a high-flux dialyzer that allow for greater removal of potential toxins and wastes in the blood that would regularly be filtered out by healthy kidneys.
High-Flux Dialyzer
DeviceA hemodialysis filter (known as a dialyzer) that is that is widely used across Canada for hemodialysis treatments.
Primary Outcome of All-Cause Mortality
Outcome data will be collected as a result of routine patient interactions with the healthcare system and will be obtained from national and provincial data repositories (with the exceptions of routine care symptoms and ESA utilization outcomes, in participating sites), enabling health records to be analyzed in a privacy-compliant manner. These datasets have high levels of completeness and validity. The primary outcome, all-cause mortality, is captured with over 99% accuracy in our data sources.
Key Secondary Outcome of Cardiovascular and Infection-Related Hospitalizations
The key secondary outcome will be time to first and recurrent cardiovascular or infection-related hospitalizations. Cardiovascular and infection-related hospitalizations will be ascertained using primary discharge ICD-10 diagnosis codes in the Canadian Institute for Health Information Discharge Abstract Database
Cardiovascular-Related Hospitalizations
Time to first and recurrent cardiovascular hospitalizations. Each component of the secondary outcome (cardiovascular-related and infection-related hospitalizations) will be examined separately.
Infection-Related Hospitalizations
Time to first and recurrent infection-related hospitalizations. Each component of the secondary outcome (cardiovascular-related and infection-related hospitalizations) will be examined separately.
Death from Cardiovascular Cause
Defined as any out-of-hospital death or death that occurred during a hospitalization for a cardiovascular cause captured in Canada in the CIHI-DAD database.
Routine Care Symptoms
Routine care symptoms assessed using the Edmonton Symptoms Assessment System Revised Renal (ESAS-r: Renal) instrument, as recorded in usual care. Data will be abstracted from routine clinical records. The ESAS-r: Renal evaluates 12 symptoms on a 0-10 scale, with assessments every 3-6 months. The minimum value is 0, meaning no experience of specified symptom. The maximum value is 10 meaning, worst possible experience of specified symptom. This will be done only in units that routinely administer this instrument and participation in reporting this outcome is optional for sites.
Healthcare-Associated Costs
The investigator will assess healthcare-associated costs in the subset of patients enrolled in Ontario using linked administrative databases with a standard method developed by the Institute for Clinical Evaluative Sciences (ICES).
Neutrophil to Lymphocyte Ratio
The ratio between the neutrophil count and lymphocyte count derived from a complete blood count measurement performed in routine care and captured in the Ontario Laboratory Information System. This measures is typically collected every 4-6 weeks as part of standard dialysis care in Ontario.
Blood Hemoglobin Concentration
Hemoglobin concentration from a complete blood count measurement performed in routine care and captured in the Ontario Laboratory Information System. This measures is typically collected every 4-6 weeks as part of standard dialysis care in Ontario.
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead sponsor
Schulich School of Medicine and Dentistry
Collaborator
ICES
Collaborator
Nipro Canada Corporation
Collaborator
London Health Sciences Centre
Collaborator
Statistics Canada
Collaborator
