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

Prospective Randomized Study Comparing the Hemodiafiltration On-line and Conventional Hemodialysis in Terms of Cost-benefit

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis; Chronic Renal Failure
• Intervention / Treatment: Device: conventional hemodialysis; Device: hemodiafiltration On-line

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 3J4
      • Centre Hospitalier Universitaire de Montréal (CHUM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional hemodialysis	Device: conventional hemodialysis
Active Comparator: hemodiafiltration On-line	Device: hemodiafiltration On-line

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
demonstrate lower need of Erythropoietin and best control of anemia in HDF	3 years
demonstrate lower need of phosphate binder and best control of phospho-calcique balance in HDF	3 years
demonstrate less hospitalization stay and cost related in HDF group	3 years
stabilisation or regression of left ventricular hypertrophy	3 years

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 24, 2013
• First Submitted That Met QC Criteria: February 26, 2015
• First Posted (Estimate): February 27, 2015

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: amyloidosis; hemodialysis; beta microglobulin
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: CE10.253