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Completed

NCT Number: NCT04799067

Hyperkalaemia Prevalence, Recurrence and Treatment in Haemodialysis

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.

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Key information

Conditions

Hyperkalemia Hemodialysis Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Beijing, Beijing Municipality, China

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

observational study

Other

no study drug involved, observational study.

Primary outcomes

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

    Time frame: 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 outcomes

  1. 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

    Time frame: 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.

  2. 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

    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

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

    Time frame: 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

  4. 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

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

  5. Proportion of HK patients treated with any potassium binders and specific proportion of each potassium binder respectively during the 24-week follow up period

    Time frame: 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

  6. 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

    Time frame: 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

  7. Mean daily dose of SPS, CPS or SZC in patients treated with any potassium binder

    Time frame: up to 24 weeks

    Mean daily dose of SPS, CPS or SZC in patients treated with any potassium binder

  8. Duration of the treatment of SPS, CPS or SZC in patients treated with any potassium binders

    Time frame: up to 24 weeks

    Duration of the treatment of SPS, CPS or SZC in patients treated with any potassium binders

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Hyperkalaemia Prevalence, Recurrence and Treatment in Haemodialysis: A Prospective Multi-centre Cohort Study

Acronym: PRECEDE-K

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 16, 2021
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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