Clinical trial NCT06940414: Prevalence and Risk Factors of Hyperkalemia in Non-Dialysis Chronic Kidney Disease Patients in Community
Official title: Prevalence and Risk Factors of Hyperkalemia in Non-Dialysis Chronic Kidney Disease Patients in a Community-Based Primary Care Setting
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hyperkalemia
Chronic Kidney Disease(CKD)
Keywords: Hyperkalemia
Chronic Kidney Disease
Community-Based
Non-Dialysis
Prevalence
Eaglenos POCT System
Lead sponsor: Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Sponsor class: OTHER_GOV
First posted: 2025-04-23
Enrollment: 1890
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-dialysis CKD patients (Stage 1-5), aged 18 years or older, recruited from 18 community health centers in Songjiang District, Shanghai.

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.

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.

Primary outcomes:
measure: Prevalence of Hyperkalemia.
timeFrame: At the time of enrollment
Secondary outcomes:
measure: Association Between Hyperkalemia and Age.
timeFrame: At the time of enrollment
measure: Association Between Hyperkalemia and CKD Stage.
timeFrame: At the time of enrollment
measure: Association Between Hyperkalemia and Blood Glucose.
timeFrame: At the time of enrollment
measure: Association Between Hyperkalemia and Creatinine.
timeFrame: At the time of enrollment
measure: Association Between Hyperkalemia and Uric Acid.
timeFrame: At the time of enrollment
measure: Association Between Hyperkalemia and Hemoglobin.
timeFrame: At the time of enrollment
measure: Performance of Hyperkalemia Prediction Model.
timeFrame: At the time of enrollment
Other outcomes:
Locations:
Study officials:
affiliation: Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
name: Xiujuan Zang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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