Prevalence and Risk Factors of Hyperkalemia in Non-Dialysis Chronic Kidney Disease Patients in Community

NCT ID: NCT06940414

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1890 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-28
• Study Completion Date: 2025-09-30

Brief Summary

The goal of this observational study is to investigate the prevalence and risk factors of hyperkalemia in community-based non-dialysis chronic kidney disease (CKD) patients. The main questions it aims to answer are:

1. What is the prevalence of hyperkalemia in non-dialysis CKD patients in a primary care setting?

2. What are the key risk factors influencing the occurrence of hyperkalemia in this population? Researchers will collect clinical and demographic data from participants across 18 community health centers and use both point-of-care testing (POCT) and laboratory-based methods to measure serum potassium levels and related parameters.

Participants will:

1. Provide blood samples for POCT and laboratory testing.

2. Participate in interviews or questionnaires to gather clinical and lifestyle information.

The findings will be used to construct a risk prediction model for hyperkalemia, aiming to optimize screening pathways and improve disease management strategies in primary care.

Detailed Description

Hyperkalemia is a common and life-threatening complication in CKD, with limited data available for non-dialysis patients in community settings. This cross-sectional study will enroll 2,000 non-dialysis CKD patients (Stages 1-5) from 18 community health centers in Songjiang, Shanghai.

The study includes:

1. Validation phase: 500 participants to validate POCT devices for measuring whole blood potassium, glucose, creatinine, uric acid, and hemoglobin.

2. Main phase: 1,500 participants to assess hyperkalemia prevalence and risk factors.

Data will be collected through:

1. POCT and laboratory testing of blood samples.

2. Structured questionnaires capturing demographics, comorbidities, and lifestyle factors.

Statistical analyses will identify key risk factors, and a predictive model will be developed to guide early screening and intervention. This study aims to improve CKD management in primary care by providing evidence for targeted hyperkalemia screening and prevention strategies.

Conditions

Hyperkalemia; Chronic Kidney Disease(CKD)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

No Intervention

This is an observational study with no interventions. POCT devices, provided by Eaglenos Sciences, Inc., are used to measure blood glucose, creatinine, uric acid, hemoglobin, and potassium levels in non-dialysis CKD patients for data collection purposes only.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged 18 years or older with stable vital signs, specifically defined as:

1. Body temperature: 36.0°C-38.0°C;

2. Pulse: 50-120 beats/min;

3. Respiratory rate: 10-24 breaths/min;

4. Blood pressure: Systolic blood pressure ≥90 mmHg and diastolic blood pressure ≥60 mmHg.

• Willing to participate in the study and sign the informed consent form.
• Hematocrit (Hct) level between 25% and 60%.
• Confirmed diagnosis of chronic kidney disease (CKD).

Exclusion Criteria

• Patients in the unstable phase of acute cardiovascular or cerebrovascular diseases (e.g., acute cerebral infarction, cerebral hemorrhage, or acute coronary syndrome).
• Patients in the unstable phase of severe acute diabetic complications (e.g., diabetic ketoacidosis or hyperosmolar hyperglycemic coma).
• Patients currently in the acute kidney injury (AKI) stage.
• Patients who have started renal replacement therapy.
• Pregnant or breastfeeding women.
• Patients currently participating in or who have participated in other clinical trials within the past six months.
• Patients unable to understand verbal or written instructions, including informed consent content.
• Patients unable to cooperate with the study procedures.
• Other conditions deemed unsuitable for participation in this clinical trial by the investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiujuan Zang

OTHER_GOV

Sponsor Role: lead

Responsible Party

Xiujuan Zang

Chief of Nephrology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xiujuan Zang, MD

Role: PRINCIPAL_INVESTIGATOR

Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Locations

Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiujuan Zang, MD

Role: CONTACT

zangxiujuan@shsmu.edu.cn

+8618918289268

Xiangyu Zhang, MMed

Role: CONTACT

zhang_xiangyu@126.com

+8618963755366

Facility Contacts

Xiujuan Zang, Doctor of Medicine

Role: primary

zangxiujuan@shsmu.edu.cn

+8618918289268

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Other Identifiers

2025-55-SJ-IRB

Identifier Type: -

Identifier Source: org_study_id