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

Hemodialysis Clinical Trial

— PHARMACO-$  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374372
• Other study ID #: CE10.253
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: December 2015

Study information

• Verified date: December 2022
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Failure
• Hemodialysis
• Kidney Failure, Chronic

Intervention

Device:
• conventional hemodialysis

• hemodiafiltration On-line

Locations

Country	Name	City	State
Canada	Centre hospitalier Universitaire de Montréal (CHUM)	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare the medication cost between the 2 groups (HD and HDF)		3 years
Primary	demonstrate lower cost of erythropoietin in HDF, with same control of anemia to HD group		3 years
Primary	demonstrate lower cost of phosphate binder in HDF, with same control of phospho calcium balance to HD group		3 years
Secondary	demonstrate lower need of Erythropoietin and best control of anemia in HDF		3 years
Secondary	demonstrate lower need of phosphate binder and best control of phospho-calcique balance in HDF		3 years
Secondary	demonstrate less hospitalization stay and cost related in HDF group		3 years
Secondary	stabilisation or regression of left ventricular hypertrophy		3 years