Hyperkalaemia Prevalence, Recurrence and Treatment in Haemodialysis

NCT ID: NCT04799067

Last Updated: 2023-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-17

Study Completion Date

2022-07-18

Brief Summary

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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

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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

Conditions

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Hyperkalemia Hemodialysis Water-Electrolyte Imbalance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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observational study

no study drug involved, observational study.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Beijing, Beijing Municipality, China

Site Status

Research Site

Guangzhou, Guangdong, China

Site Status

Research Site

Shenzhen, Guangdong, China

Site Status

Research Site

Shijiazhuang, Hebei, China

Site Status

Research Site

Taihe, Hubei, China

Site Status

Research Site

Nanchang, Jiangxi, China

Site Status

Research Site

Shenyang, Liaoning, China

Site Status

Research Site

Shanghai, Shanghai Municipality, China

Site Status

Research Site

Taiyuan, Shanxi, China

Site Status

Research Site

Yangquan, Shanxi, China

Site Status

Research Site

Ningbo, Zhejiang, China

Site Status

Research Site

Wenzhou, Zhejiang, China

Site Status

Countries

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China

References

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Jin H, Lu R, Zhang L, Yao L, Shao G, Zuo L, Qin S, Zhang X, Zhang Q, Yu W, Luo Q, Ren Y, Peng H, Xiao J, Yang Q, Chen Q, Shi Y, Ni Z. Hyperkalemia burden and treatment patterns in Chinese patients on hemodialysis: final analysis of a prospective multicenter cohort study (PRECEDE-K). Ren Fail. 2024 Dec;46(2):2384585. doi: 10.1080/0886022X.2024.2384585. Epub 2024 Sep 9.

Reference Type DERIVED
PMID: 39252179 (View on PubMed)

Ni Z, Jin H, Lu R, Zhang L, Yao L, Shao G, Zuo L, Qin S, Zhang X, Zhang Q, Yu W, Luo Q, Ren Y, Peng H, Xiao J, Yang Q, Chen Q, Shi Y; PRECEDE-K study group. Hyperkalaemia prevalence and dialysis patterns in Chinese patients on haemodialysis: an interim analysis of a prospective cohort study (PRECEDE-K). BMC Nephrol. 2023 Aug 9;24(1):233. doi: 10.1186/s12882-023-03261-8.

Reference Type DERIVED
PMID: 37559023 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34937724 (View on PubMed)

Other Identifiers

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No secondary ID yet

Identifier Type: OTHER

Identifier Source: secondary_id

D9480R00033

Identifier Type: -

Identifier Source: org_study_id

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