Clinical trial NCT04799067: Hyperkalaemia Prevalence, Recurrence and Treatment in Haemodialysis
Official title: Hyperkalaemia Prevalence, Recurrence and Treatment in Haemodialysis: A Prospective Multi-centre Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperkalemia
Hemodialysis
Water-Electrolyte Imbalance
Keywords: Hyperkalemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-03-16
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ESRD patients receiving HD treatment twice a week or thrice a week.

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

1. Patient aged ≥ 18 years at the time of signing the informed consent.
2. Patients with ESRD and on haemodialysis (HD)
3. The HD treatment frequency is ≥2 sessions per week
4. Capable of giving signed informed consent

Exclusion Criteria:

1. Acute kidney injury
2. Expected to receive renal transplantation within 6 months
3. Intracranial haemorrhage or elevated intracranial pressure within one month before enrolment
4. Shock that cannot be corrected by drugs within one month before enrolment
5. Failure to establish vascular access
6. Has been receiving peritoneal dialysis
7. Not suitable for this study judged by investigators

Primary outcomes:
measure: Proportion of patients experiencing any HK at the study enrolment or during a 24-week follow-up
timeFrame: up to 24 weeks
Secondary outcomes:
measure: 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
timeFrame: up to 24 weeks
measure: 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
timeFrame: up to 24 weeks
measure: Intradialytic potassium shift at LIDI during the first week after patient enrolment
timeFrame: up to 1 week
measure: Serum K+ at LIDI and SIDI in patients receiving HD thrice a week during the first week after patient enrolment
timeFrame: up to 1 week
measure: Proportion of HK patients treated with any potassium binders and specific proportion of each potassium binder respectively during the 24-week follow up period
timeFrame: up to 24 weeks
measure: 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
timeFrame: up to 24 weeks
measure: Mean daily dose of SPS, CPS or SZC in patients treated with any potassium binder
timeFrame: up to 24 weeks
measure: Duration of the treatment of SPS, CPS or SZC in patients treated with any potassium binders
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Shenzhen
country: China
facility: Research Site
state: Guangdong
city: Shijiazhuang
country: China
facility: Research Site
state: Hebei
city: Taihe
country: China
facility: Research Site
state: Hubei
city: Nanchang
country: China
facility: Research Site
state: Jiangxi
city: Shenyang
country: China
facility: Research Site
state: Liaoning
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Taiyuan
country: China
facility: Research Site
state: Shanxi
city: Yangquan
country: China
facility: Research Site
state: Shanxi
city: Ningbo
country: China
facility: Research Site
state: Zhejiang
city: Wenzhou
country: China
facility: Research Site
state: Zhejiang
Study officials:
References:
citation: Ni Z, Jin H, Lu R, Zuo L, Yu W, Ren Y, Yang Q, Xiao J, Zhang Q, Zhang L, Zhang X, Chen Q, Chen C, Shao G, Luo Q, Yao L, Qin S, Peng H, Zhao Q; PRECEDE-K Study group. Hyperkalaemia prevalence, recurrence and treatment in patients on haemodialysis in China: protocol for a prospective multicentre cohort study (PRECEDE-K). BMJ Open. 2021 Dec 22;11(12):e055770. doi: 10.1136/bmjopen-2021-055770.