Hyperkalaemia Prevalence, Recurrence and Treatment in Haemodialysis (PRECEDE-K)

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

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis; Water-Electrolyte Imbalance; Hyperkalemia
• Intervention / Treatment: Other: observational study

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 Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Research Site
  • Guangdong
    • Guangzhou, Guangdong, China
      • Research Site
    • Shenzhen, Guangdong, China
      • Research Site
  • Hebei
    • Shijiazhuang, Hebei, China
      • Research Site
  • Hubei
    • Taihe, Hubei, China
      • Research Site
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Research Site
  • Liaoning
    • Shenyang, Liaoning, China
      • Research Site
  • Shanghai
    • Shanghai, Shanghai, China, 2000127
      • Research Site
  • Shanxi
    • Taiyuan, Shanxi, China
      • Research Site
    • Yangquan, Shanxi, China
      • Research Site
  • Zhejiang
    • Ningbo, Zhejiang, China
      • Research Site
    • Wenzhou, Zhejiang, China
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

ESRD patients receiving HD treatment twice a week or thrice a week.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	Intradialytic potassium shift (defined as the difference between pre- and post-dialysis K+)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	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	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	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	Proportion of HK events treated with any potassium binders 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	Mean daily dose of SPS, CPS or SZC in patients treated with any potassium binder	up to 24 weeks
Duration of the treatment of SPS, CPS or SZC in patients treated with any potassium binders	Duration of the treatment of SPS, CPS or SZC in patients treated with any potassium binders	up to 24 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• 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.

Helpful Links

• redacted CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Actual): July 18, 2022
• Study Completion (Actual): July 18, 2022

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Hyperkalemia
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease Attributes; Recurrence; Hyperkalemia; Water-Electrolyte Imbalance
• Other Study ID Numbers: D9480R00033; No secondary ID yet (Other Identifier: No secondary ID yet)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No