Hyperkalaemia Prevalence, Recurrence and Treatment in Haemodialysis

Completed

• Conditions: Hyperkalemia; Water-Electrolyte Imbalance; Hemodialysis

• Registration Number: NCT04799067
• Lead Sponsor: AstraZeneca

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

Study Timeline

• Study First Submitted: 2021-02-24
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-16
• Study Start: 2021-05-17
• Primary Completion: 2022-07-18
• Study Completion: 2022-07-18
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-05
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients experiencing any HK at the study enrolment or during a 24-week follow-up	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

Secondary Outcome Measures

Name	Time	Method
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	Proportion of patients experiencing HK recurrence (defined as any HK event after the first HK event) within 1, 2, 3, 4, 5 or 6 months (if applicable) during a 24-week follow-up including enrolment assessment. A HK event is defined as any serum K+\> 5.0 mmol/L within an interdialytic interval, which is usually two to three days.
Duration of the treatment of SPS, CPS or SZC in patients treated with any potassium binders	up to 24 weeks	Duration of the treatment of SPS, CPS or SZC in patients treated with any potassium binders
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	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
Intradialytic potassium shift at LIDI during the first week after patient enrolment	up to 1 week	Intradialytic potassium shift (defined as the difference between pre- and post-dialysis K+)at LIDI during the first week after patient enrolment
Serum K+ at LIDI and SIDI in patients receiving HD thrice a week 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
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 patients treated with any potassium binders including sodium polystyrene sulfonate ( calcium polystyrene sulfonate (CPS) or sodium zirconium cyclosilicate (SZC), and specific proportion of each potassium binder respectively during the 24-week follow up period
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	Proportion of HK events treated with any potassium binders among total number of HK events during the 24-week follow up period
Mean daily dose of SPS, CPS or SZC in patients treated with any potassium binder	up to 24 weeks	Mean daily dose of SPS, CPS or SZC in patients treated with any potassium binder

Trial Locations

Locations (1)

Research Site; 🇨🇳 Wenzhou, Zhejiang, China