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Comparing the Hemodiafiltration On-line and Conventional Hemodialysis in Terms of Cost-benefit (PHARMACO-$)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02374372
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : December 8, 2022
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Study Description
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Brief Summary:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: conventional hemodialysis
conventional hemodialysis
 Device: conventional hemodialysis
Active Comparator: hemodiafiltration On-line
hemodiafiltration On-line
 Device: hemodiafiltration On-line


Outcome Measures
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Primary Outcome Measures :
  1. compare the medication cost between the 2 groups (HD and HDF) [ Time Frame: 3 years ]
  2. demonstrate lower cost of erythropoietin in HDF, with same control of anemia to HD group [ Time Frame: 3 years ]
  3. demonstrate lower cost of phosphate binder in HDF, with same control of phospho calcium balance to HD group [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. demonstrate lower need of Erythropoietin and best control of anemia in HDF [ Time Frame: 3 years ]
  2. demonstrate lower need of phosphate binder and best control of phospho-calcique balance in HDF [ Time Frame: 3 years ]
  3. demonstrate less hospitalization stay and cost related in HDF group [ Time Frame: 3 years ]
  4. stabilisation or regression of left ventricular hypertrophy [ Time Frame: 3 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • more than 18 years old,
  • able to consent,
  • patient needs to be on hemodialysis more than 8-12 hours a week (2-3 sessions)

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Canada, Quebec
Centre hospitalier Universitaire de Montréal (CHUM)
Montréal, Quebec, Canada, H2X 3J4
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
More Information
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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02374372    
Other Study ID Numbers: CE10.253
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: December 8, 2022
Last Verified: December 2022
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
hemodialysis
beta microglobulin
amyloidosis
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic