The Prevalence and Risk Factors of Hyperkalemia in the Outpatient Setting.
Chadapa Sevamontree, Supreeya Jintajirapan, Pran Phakdeekitcharoen...
https://pubmed.ncbi.nlm.nih.gov/38292832Actively Recruiting
Age: 18Years +
All Genders
ID06940414
Prevalence and Risk Factors of Hyperkalemia in Non-Dialysis Chronic Kidney Disease Patients in Community-Based Primary Care
Led by Xiujuan Zang · Updated on 2025-07-11
1890
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how common hyperkalemia is and what risk factors contribute to it among patients with chronic kidney disease (CKD) who are not on dialysis. This observational study focuses on people receiving primary care in the community and aims to improve understanding by collecting detailed clinical and lifestyle information. The study is being conducted across 18 community health centers and hopes to create a risk prediction model to guide better screening and management of hyperkalemia in CKD patients. The study includes two phases: an initial validation phase with 500 participants to check the accuracy of point-of-care testing (POCT) devices measuring blood potassium, glucose, creatinine, uric acid, and hemoglobin, followed by a main phase with 1,500 participants to assess hyperkalemia prevalence and related risk factors. Blood samples are collected for both POCT and laboratory testing, and participants complete structured questionnaires about their demographics, health conditions, and lifestyle habits. No treatments or interventions are given, as this is an observational study. Participants provide blood samples and answer interviews or questionnaires during their enrollment visit. Researchers measure potassium levels and other blood markers using both POCT and laboratory methods. They also collect data on age, CKD stage, and other health factors to analyze their connection to hyperkalemia. The main outcome is the prevalence of hyperkalemia at enrollment. The study findings will help develop a predictive model to improve early detection and management of hyperkalemia in community-based CKD care.
CONDITIONS
Brief Title
Prevalence and Risk Factors of Hyperkalemia in Non-Dialysis Chronic Kidney Disease Patients in Community
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older with stable vital signs including body temperature between 36.0°C and 38.0°C
- Pulse rate between 50 and 120 beats per minute
- Respiratory rate between 10 and 24 breaths per minute
- Blood pressure with systolic ≥90 mmHg and diastolic ≥60 mmHg
- Willing to participate and sign informed consent
- Hematocrit level between 25% and 60%
- Confirmed diagnosis of chronic kidney disease
You will not qualify if you...
- Unstable acute cardiovascular or cerebrovascular diseases such as cerebral infarction, cerebral hemorrhage, or acute coronary syndrome
- Unstable severe acute diabetic complications like diabetic ketoacidosis or hyperosmolar hyperglycemic coma
- Currently in acute kidney injury stage
- Started renal replacement therapy
- Pregnant or breastfeeding women
- Participation in other clinical trials within the past six months
- Unable to understand or cooperate with study procedures
- Other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 day
Participants undergo point-of-care testing (POCT) and laboratory blood tests, and complete structured questionnaires to collect data on potassium levels, kidney function, and other health indicators.
1 visit (in-person)
Surveillance
Duration - At the time of enrollment
Participants are observed to assess the prevalence and risk factors of hyperkalemia based on collected data without any intervention.
No additional visits
Trial Site Locations
Total: 1 location
1
Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
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Research Team
X
Xiujuan Zang, MD
X
Xiangyu Zhang, MMed
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Hyperkalemia: Pharmacotherapies and Clinical Considerations.
Evan S Sinnathamby, Kelly T Banh, William T Barham...
https://pubmed.ncbi.nlm.nih.gov/38406030The frequency of hyperkalemia and its significance in chronic kidney disease.
Lisa M Einhorn, Min Zhan, Van Doren Hsu...
https://pubmed.ncbi.nlm.nih.gov/19546417Hyperkalemia and Hypokalemia in CKD: Prevalence, Risk Factors, and Clinical Outcomes.
Sarah Gilligan, Kalani L Raphael
https://pubmed.ncbi.nlm.nih.gov/29031358Chronic hyperkalemia in non-dialysis CKD: controversial issues in nephrology practice.
Luca De Nicola, Luca Di Lullo, Ernesto Paoletti...
https://pubmed.ncbi.nlm.nih.gov/29882199How Dangerous Is Hyperkalemia?
John R Montford, Stuart Linas
https://pubmed.ncbi.nlm.nih.gov/28778861Prevalence of chronic kidney disease in China: a cross-sectional survey.
Luxia Zhang, Fang Wang, Li Wang...
https://pubmed.ncbi.nlm.nih.gov/22386035Chronic kidney disease and cardiovascular risk in six regions of the world (ISN-KDDC): a cross-sectional study.
Bogdan Ene-Iordache, Norberto Perico, Boris Bikbov...
https://pubmed.ncbi.nlm.nih.gov/27102194