How common high potassium is and what increases the risk in non-dialysis CKD patients in the community

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

This project will test how common high potassium is and try to find which health and lifestyle factors raise the risk in adults with chronic kidney disease who are not on dialysis.

Quick facts

• Study type: Observational
• Enrollment: 1890 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine (other gov)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06940414 on ClinicalTrials.gov

What this trial studies

This is a cross-sectional, community-based observational study enrolling 2,000 non-dialysis adults with CKD (stages 1–5) from 18 community health centers in Songjiang, Shanghai. A 500-participant validation phase will compare point-of-care testing (POCT) devices with laboratory assays, followed by a 1,500-participant main phase to measure hyperkalemia prevalence and collect clinical and lifestyle data. Participants provide blood samples for POCT and central laboratory testing and complete structured questionnaires on comorbidities and behaviors. Statistical analysis will identify key risk factors and produce a predictive model to guide targeted screening in primary care.

Who should consider this trial

Good fit: Adults aged 18 or older with a confirmed diagnosis of chronic kidney disease (stages 1–5) who are not on dialysis, have stable vital signs, hematocrit between 25% and 60%, and can provide informed consent.

Not a fit: People currently on dialysis, in acute kidney injury, with unstable severe cardiovascular or diabetic complications, or who are pregnant or breastfeeding are excluded and unlikely to benefit from this project.

Why it matters

Potential benefit: If successful, the findings could help primary care providers target screening and prevent dangerous high potassium episodes in non-dialysis CKD patients.

How similar studies have performed: Previous research has described hyperkalemia prevalence and risk factors in CKD, but large community-based POCT validation and a primary-care predictive model of this scale are relatively novel.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Xiujuan Zang, MD — Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
• Study coordinator: Xiujuan Zang, MD

Conditions: Hyperkalemia, Chronic Kidney Disease, Community-Based, Non-Dialysis, Prevalence, Eaglenos POCT System