Comparing the Hemodiafiltration On-line and Conventional Hemodialysis in Terms of Cost-benefit (PHARMACO-$)
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|ClinicalTrials.gov Identifier: NCT02374372|
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : December 8, 2022
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The site where the clinical trial will be conducted is at the St-Luc hospital from the CHUM. This is a prospective randomized study that will compare the two treatment modalities, HD and HDF, through economics and pharmaco-economics parameters.
Patients, who had previously been randomized in the CONTRAST study, will remain in their respective group and monitoring will continue. The next patients will be randomized in the same way (1: 1) using the same inclusion and exclusion criteria. HDF randomized patients will receive post-dilution standard reinjection (at least 100ml/min or 6 liter/hr). In rare cases, HDF patients can briefly have reinjection on a pre-dilution mode (if heparin need to be avoided for example) and the reinjection flow should be adjusted accordingly (200ml/min).
Length and frequency of sessions will be the same in the 2 groups. Blood tests will not change and will be the same than those used as routine assessments. Metabolic control of patients will be maintained according to the guidelines. Patients will be monitored for a minimum of 3 years. A set of demographic and clinical data will be collected from patient medical records and throughout the study.
Biochemical data as part of the usual blood tests of dialysis patients will be collected each month as well as will be stored and analyzed information about the annual cardiac ultrasounds.
All events will be scored (hospitalizations, patterns, duration) and the list and cost of drugs will be compiled every three months. These data will be useful in the economic analysis comparing the two treatment modalities.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Renal Failure Hemodialysis||Device: conventional hemodialysis Device: hemodiafiltration On-line||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Study Comparing the Hemodiafiltration On-line and Conventional Hemodialysis in Terms of Cost-benefit|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Active Comparator: conventional hemodialysis
Device: conventional hemodialysis
Active Comparator: hemodiafiltration On-line
Device: hemodiafiltration On-line
- compare the medication cost between the 2 groups (HD and HDF) [ Time Frame: 3 years ]
- demonstrate lower cost of erythropoietin in HDF, with same control of anemia to HD group [ Time Frame: 3 years ]
- demonstrate lower cost of phosphate binder in HDF, with same control of phospho calcium balance to HD group [ Time Frame: 3 years ]
- demonstrate lower need of Erythropoietin and best control of anemia in HDF [ Time Frame: 3 years ]
- demonstrate lower need of phosphate binder and best control of phospho-calcique balance in HDF [ Time Frame: 3 years ]
- demonstrate less hospitalization stay and cost related in HDF group [ Time Frame: 3 years ]
- stabilisation or regression of left ventricular hypertrophy [ Time Frame: 3 years ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- more than 18 years old,
- able to consent,
- patient needs to be on hemodialysis more than 8-12 hours a week (2-3 sessions)
- severe none compliance (often missing sessions without good reasons),
- life expectation less than 3 months,
- treated with high-flux filters in the last 6 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374372
|Centre hospitalier Universitaire de Montréal (CHUM)|
|Montréal, Quebec, Canada, H2X 3J4|
|Responsible Party:||Centre hospitalier de l'Université de Montréal (CHUM)|
|Other Study ID Numbers:||
|First Posted:||February 27, 2015 Key Record Dates|
|Last Update Posted:||December 8, 2022|
|Last Verified:||December 2022|
Kidney Failure, Chronic
Renal Insufficiency, Chronic