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

NCT ID: NCT02374372

Last Updated: 2022-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Chronic Renal Failure; Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

conventional hemodialysis

conventional hemodialysis

Group Type: ACTIVE_COMPARATOR

conventional hemodialysis

Intervention Type: DEVICE

hemodiafiltration On-line

hemodiafiltration On-line

Group Type: ACTIVE_COMPARATOR

hemodiafiltration On-line

Intervention Type: DEVICE

Interventions

conventional hemodialysis

Intervention Type: DEVICE

hemodiafiltration On-line

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre hospitalier Universitaire de Montréal (CHUM)

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

CE10.253

Identifier Type: -

Identifier Source: org_study_id