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临床试验/NCT02374372
NCT02374372已完成不适用

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

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2011年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
demonstrate lower cost of phosphate binder in HDF, with same control of phospho calcium balance to HD group

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

conventional hemodialysis

Active Comparator

conventional hemodialysis

干预措施: conventional hemodialysis (Device)

hemodiafiltration On-line

Active Comparator

hemodiafiltration On-line

干预措施: hemodiafiltration On-line (Device)

结局指标

主要结局

demonstrate lower cost of phosphate binder in HDF, with same control of phospho calcium balance to HD group

时间窗: 3 years

compare the medication cost between the 2 groups (HD and HDF)

时间窗: 3 years

demonstrate lower cost of erythropoietin in HDF, with same control of anemia to HD group

时间窗: 3 years

次要结局

  • demonstrate less hospitalization stay and cost related in HDF group(3 years)
  • stabilisation or regression of left ventricular hypertrophy(3 years)
  • 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)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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