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

NCT06940414 | Recruiting

• 1 other identifier: 2025-55-SJ-IRB
• Study Type: observational
• Target: 1,890
• Locations: 1 country
• Sites: 1

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. 1.What is the prevalence of hyperkalemia in non-dialysis CKD patients in a primary care setting?
2. 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.
3. 3.Provide blood samples for POCT and laboratory testing.
4. 4.Participate in interviews or questionnaires to gather clinical and lifestyle information.

Conditions

Hyperkalemia; Chronic Kidney Disease(CKD)

Keywords

Hyperkalemia; Chronic Kidney Disease; Community-Based; Non-Dialysis; Prevalence; Eaglenos POCT System

Outcome Measures

Primary Outcomes (1)

• Prevalence of Hyperkalemia.

  The proportion of non-dialysis CKD patients with hyperkalemia, defined as a blood potassium level greater than 5.0 mmol/L, measured using point-of-care testing (POCT) at enrollment.

  At the time of enrollment

Secondary Outcomes (7)

• Association Between Hyperkalemia and Age.

  At the time of enrollment

• Association Between Hyperkalemia and CKD Stage.

  At the time of enrollment

• Association Between Hyperkalemia and Blood Glucose.

  At the time of enrollment

• Association Between Hyperkalemia and Creatinine.

  At the time of enrollment

• Association Between Hyperkalemia and Uric Acid.

  At the time of enrollment

Interventions

No Intervention OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Aged 18 years or older with stable vital signs, specifically defined as:
• Body temperature: 36.0°C-38.0°C;
• Pulse: 50-120 beats/min;
• Respiratory rate: 10-24 breaths/min;
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiujuan Zang: lead

Study Sites (1)

Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (8)

• Sevamontree C, Jintajirapan S, Phakdeekitcharoen P, Phakdeekitcharoen B. The Prevalence and Risk Factors of Hyperkalemia in the Outpatient Setting. Int J Nephrol. 2024 Jan 22;2024:5694131. doi: 10.1155/2024/5694131. eCollection 2024.

  PMID: 38292832 BACKGROUND

• Sinnathamby ES, Banh KT, Barham WT, Hernandez TD, De Witt AJ, Wenger DM, Klapper VG, McGregor D, Paladini A, Ahmadzadeh S, Shekoohi S, Kaye AD, Varrassi G. Hyperkalemia: Pharmacotherapies and Clinical Considerations. Cureus. 2024 Jan 26;16(1):e52994. doi: 10.7759/cureus.52994. eCollection 2024 Jan.

  PMID: 38406030 BACKGROUND

• Einhorn LM, Zhan M, Hsu VD, Walker LD, Moen MF, Seliger SL, Weir MR, Fink JC. The frequency of hyperkalemia and its significance in chronic kidney disease. Arch Intern Med. 2009 Jun 22;169(12):1156-62. doi: 10.1001/archinternmed.2009.132.

  PMID: 19546417 BACKGROUND

• Gilligan S, Raphael KL. Hyperkalemia and Hypokalemia in CKD: Prevalence, Risk Factors, and Clinical Outcomes. Adv Chronic Kidney Dis. 2017 Sep;24(5):315-318. doi: 10.1053/j.ackd.2017.06.004.

  PMID: 29031358 BACKGROUND

• De Nicola L, Di Lullo L, Paoletti E, Cupisti A, Bianchi S. Chronic hyperkalemia in non-dialysis CKD: controversial issues in nephrology practice. J Nephrol. 2018 Oct;31(5):653-664. doi: 10.1007/s40620-018-0502-6. Epub 2018 Jun 7.

  PMID: 29882199 BACKGROUND

• Montford JR, Linas S. How Dangerous Is Hyperkalemia? J Am Soc Nephrol. 2017 Nov;28(11):3155-3165. doi: 10.1681/ASN.2016121344. Epub 2017 Aug 4.

  PMID: 28778861 BACKGROUND

• Zhang L, Wang F, Wang L, Wang W, Liu B, Liu J, Chen M, He Q, Liao Y, Yu X, Chen N, Zhang JE, Hu Z, Liu F, Hong D, Ma L, Liu H, Zhou X, Chen J, Pan L, Chen W, Wang W, Li X, Wang H. Prevalence of chronic kidney disease in China: a cross-sectional survey. Lancet. 2012 Mar 3;379(9818):815-22. doi: 10.1016/S0140-6736(12)60033-6.

  PMID: 22386035 BACKGROUND

• Ene-Iordache B, Perico N, Bikbov B, Carminati S, Remuzzi A, Perna A, Islam N, Bravo RF, Aleckovic-Halilovic M, Zou H, Zhang L, Gouda Z, Tchokhonelidze I, Abraham G, Mahdavi-Mazdeh M, Gallieni M, Codreanu I, Togtokh A, Sharma SK, Koirala P, Uprety S, Ulasi I, Remuzzi G. Chronic kidney disease and cardiovascular risk in six regions of the world (ISN-KDDC): a cross-sectional study. Lancet Glob Health. 2016 May;4(5):e307-19. doi: 10.1016/S2214-109X(16)00071-1.

  PMID: 27102194 BACKGROUND

MeSH Terms

Conditions

Hyperkalemia; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiujuan Zang, MD

  Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiujuan Zang, MD

CONTACT

+8618918289268; zangxiujuan@shsmu.edu.cn

Xiangyu Zhang, MMed

CONTACT

+8618963755366; zhang_xiangyu@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Nephrology

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 23, 2025
• Study Start: April 28, 2025
• Primary Completion: July 31, 2025
• Study Completion: September 30, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication
• Access Criteria: Data will be made available to qualified researchers upon submission of a research proposal and executionof a data use agreement. Data access will be granted after the final study results are published and after anethical review by the institution's ethics board. Data sharing will be coordinated via email. Qualifiedresearchers can contact zxyykjb@163.com to request access to the data.

Locations

CN (1)