Hyperkalaemia Prevalence, Recurrence and Treatment in Haemodialysis: A Prospective Multi-centre Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Proportion of patients experiencing any HK at the study enrolment or during a 24-week follow-up
研究概览
简要总结
The objective of this study is to evaluate the prevalence and recurrence of Hyperkalaemia (HK) in Chinese HD patients and to understand the treatment pattern of HK in China.
详细描述
This is a prospective, cohort study. This study will include approximate 600 End Stage Renal Disease (ESRD) patients receiving Haemodialysis (HD) treatment twice a week or thrice a week.
The assessments at enrolment and in follow-up are summarized as follow:
Enrolment - Patients will be in Long Interdialytic interval (LIDI) at enrolment (V1). Demographic characteristics, medical history, etiology of ESRD, concomitant medications, dialysis vintage, an electrocardiogram (ECG), a pre-dialysis serum potassium measurement and a post- dialysis serum potassium measurement, blood routine, blood gas analysis and other blood biochemistry measurements, etc., will be obtained.
Follow-up - Potassium measurements, including pre-dialysis potassium measurements at LIDI once every month (V3-V8), pre-dialysis potassium at SIDI during the first week (V2) for patients in HD thrice a week specifically, will be obtained. Concomitant medications, blood routine, blood gas analysis and other blood biochemistry measurements, etc., will be obtained
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient aged ≥ 18 years at the time of signing the informed consent.
- •Patients with ESRD and on haemodialysis (HD)
- •The HD treatment frequency is ≥2 sessions per week
- •Capable of giving signed informed consent
排除标准
- •Acute kidney injury
- •Expected to receive renal transplantation within 6 months
- •Intracranial haemorrhage or elevated intracranial pressure within one month before enrolment
- •Shock that cannot be corrected by drugs within one month before enrolment
- •Failure to establish vascular access
- •Has been receiving peritoneal dialysis
- •Not suitable for this study judged by investigators
结局指标
主要结局
Proportion of patients experiencing any HK at the study enrolment or during a 24-week follow-up
时间窗: up to 24 weeks
Proportion of patients experiencing any HK (defined as serum potassium \> 5.0 mmol/L) at the study enrolment or during a 24-week follow-up
次要结局
- Proportion of patients experiencing HK recurrence within 1, 2, 3, 4, 5 or 6 months (if applicable) during a 24-week follow-up including enrolment assessment(up to 24 weeks)
- Duration of the treatment of SPS, CPS or SZC in patients treated with any potassium binders(up to 24 weeks)
- Proportion of patients with 2, 3, 4, 5, 6 or more than 6 events of HK during a 24-week follow-up including enrolment assessment(up to 24 weeks)
- Intradialytic potassium shift at LIDI during the first week after patient enrolment(up to 1 week)
- Serum K+ at LIDI and SIDI in patients receiving HD thrice a week during the first week after patient enrolment(up to 1 week)
- Proportion of HK patients treated with any potassium binders and specific proportion of each potassium binder respectively during the 24-week follow up period(up to 24 weeks)
- Proportion of HK events treated with any potassium binders including SPS, CPS or SZC among total number of HK events during the 24-week follow up period(up to 24 weeks)
- Mean daily dose of SPS, CPS or SZC in patients treated with any potassium binder(up to 24 weeks)