Dial-Bicarb Trial: Effects of a Lower vs. Higher Concentration of Dialysate Bicarbonate for People Receiving Maintenance Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 14,000
- 主要终点
- Non-elective hospitalizations
研究概览
简要总结
This is a pragmatic, two-arm, parallel-group, open-label, individual-randomized, superiority trial that will be conducted in hemodialysis units across Ontario. Patients at each dialysis unit will be randomly allocated into one of two study arms in a 1:1 ratio to receive a dialysate bicarbonate concentration of either 32 or 38 mmol/L. The intervention will be embedded into routine care and delivered by hemodialysis unit personnel.
详细描述
Background: Bicarbonate is added to hemodialysis fluids to correct the metabolic acidosis that arises from kidney failure. Some dialysis centres in Canada add bicarbonate to a level of 32 mmol/L, while other centres add bicarbonate to a level of 38 mmol/L. It is unknown whether one level is better for people's health.
Objective: In patients receiving maintenance hemodialysis, to determine if providing a lower versus higher concentration of dialysate bicarbonate (32 versus 38 mmol/L) alters the risk of outcomes important to patients and their care providers.
Design, Setting, and Participants: This is a pragmatic, two-arm, parallel-group, open-label, individual-randomized, superiority trial that will be conducted in hemodialysis centres across Ontario. Patients at each dialysis centre will be randomly allocated into one of two study arms in a 1:1 ratio to receive a dialysate bicarbonate concentration of either 32 or 38 mmol/L. The intervention will be embedded into routine care and delivered by hemodialysis centre personnel. The concentration of dialysate bicarbonate is altered for a hemodialysis session through a simple setting on the machine.
Altered approach to patient consent: The study team, which includes patient partners, proposes an opt-out altered approach to patient consent to receive the trial-assigned concentration of dialysate bicarbonate. This is under a framework that Dial-Bicarb fits the required parameters to do so, as constructed in Canada's Tri-Council Policy Statement-2 (TCPS-2) Article 3.7A.
Primary Outcome: Two primary outcomes, all-cause mortality and recurrent all-cause non-elective hospitalizations.
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
- •The dialysis centre director and all nephrologists who provide care in the centre agree to trial participation.
- •Adult patients 18 years of age and older, with a health card number, enter the trial after they receive hemodialysis for at least 90 days (about 3 months) so that patients with acute kidney injury who recover kidney function are excluded.
排除标准
- •Participating centres are instructed that patients on in-centre nocturnal hemodialysis or in-centre frequent (greater than four times weekly) hemodialysis are not in the trial (and do not receive the allocated intervention), since these patients usually receive dialysate bicarbonate concentrations ≤32mmol/L as standard care (based on Ontario registry data, these modalities represent <5% of the hemodialysis patient population).
研究组 & 干预措施
Lower dialysate bicarbonate concentration (32 versus mmol/L)
Patients at each dialysis unit will be randomly allocated into one of two study arms in a 1:1 ratio to receive a dialysate bicarbonate concentration of 32 mmol/L.
干预措施: Bicarbonate (Other)
Higher dialysate bicarbonate concentration (38 mmol/L)
Patients at each dialysis unit will be randomly allocated into one of two study arms in a 1:1 ratio to receive a dialysate bicarbonate concentration of 38 mmol/L.
干预措施: Bicarbonate (Other)
结局指标
主要结局
Non-elective hospitalizations
时间窗: Duration of the study, 4 years.
All-cause recurrent non-elective hospitalizations
Mortality
时间窗: Duration of the study, 4 years.
All-cause mortality
次要结局
- Hospitalizations and fractures(Duration of the study, 4 years.)