NCT06940414

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

Prevalence and Risk Factors of Hyperkalemia in Non-Dialysis Chronic Kidney Disease Patients in a Community-Based Primary Care Setting

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,890 (estimated)
• Sponsor: Xiujuan Zang · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2025-04-28
• Primary completion: 2025-07-31
• Completion: 2025-09-30
• First posted: 2025-04-23
• Last updated: 2025-07-11

Locations

1 site across 1 country: China