Hyperkalaemia Prevalence, Recurrence and Treatment in Haemodialysis

AstraZeneca600 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

600

Conditions

Hyperkalemia Hemodialysis Water-Electrolyte Imbalance

Interventions

observational studyOTHER

no study drug involved, observational study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Research Site

Beijing, Beijing Municipality, China

Research Site

Guangzhou, Guangdong, China

Research Site

Shenzhen, Guangdong, China

Research Site

Shijiazhuang, Hebei, China

Outcomes

Primary Outcomes

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

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

Time frame: up to 24 weeks

Secondary Outcomes

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

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.

Time frame: 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

Time frame: up to 24 weeks

Intradialytic potassium shift at LIDI during the first week after patient enrolment

Intradialytic potassium shift (defined as the difference between pre- and post-dialysis K+)at LIDI during the first week after patient enrolment

Time frame: up to 1 week

Serum K+ at LIDI and SIDI in patients receiving HD thrice a week during the first week after patient enrolment

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.