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NCT Number: NCT02374372

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional hemodialysis

Device

hemodiafiltration On-line

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

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

Acronym: PHARMACO-$

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 27, 2015
Registry last updated
Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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