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

NCT02374372 | Completed

• 1 other identifier: CE10.253
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Keywords

hemodialysis; beta microglobulin; amyloidosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (2)

conventional hemodialysis

ACTIVE COMPARATOR

conventional hemodialysis

Device: conventional hemodialysis

hemodiafiltration On-line

ACTIVE COMPARATOR

hemodiafiltration On-line

Device: hemodiafiltration On-line

Interventions

conventional hemodialysis DEVICE

conventional hemodialysis

hemodiafiltration On-line DEVICE

hemodiafiltration On-line

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Centre hospitalier Universitaire de Montréal (CHUM)

Montreal, Quebec, H2X 3J4, Canada

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Amyloidosis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: February 27, 2015
• Study Start: January 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 8, 2022

Record last verified: 2022-12

Locations

CA (1)