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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: zangxiujuan@shsmu.edu.cn
• Phone: +8618918289268

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.