standard hyperkalemia management implementation: The interventions include HK disease management and quality audits for health care professionals (HCPs) and patients (Figure 1). The main contents of HK disease management in CKD include a standardized clinical pathway based on guideline adoption and medical trainings to educate HCPs and patients.
Study summary
This is a prospective, multi-center, single-arm study to evaluate the impact of implementation of guideline determined medical therapy (GDMT) for quality control improvement in non-dialysis chronic kidney disease (CKD-ND) patients, as well as provide evidence for standard hyperkalemia management with RAASi optimization in China CKD-ND patients.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥18 years, at the time of signing the informed consent.
2. HK (sK+ \> 5.0 mmol/L) within 48 hours before enrolment.
3. Patients diagnosed as chronic kidney disease with eGFR\>10 ml/min/1.73m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation (2021). See 8.3.4 for detailed equation.
4. Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Exclusion Criteria:
1. Patients on dialysis.
2. Pseudohyperkalemia signs and symptoms, such as hemolyzed blood specimen due to excessive fist clenching to make veins prominent, difficult or traumatic venipuncture, or history of severe leukocytosis or thrombocytosis.
3. Patients with acute kidney injury (AKI) or diabetic ketoacidosis (DKA).
4. Patients with cardiac arrhythmias that require immediate treatment
5. Patients scheduled for renal transplant or with a history of renal transplant.
6. Life expectancy \< 48 weeks.
7. History of malignancy except for:
7.1 Malignancy treated with curative intent and with no known active disease within 3 years before the enrolment and of low potential risk for recurrence.
7.2 Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease.
7.3 Adequately treated carcinoma in situ without evidence of disease.
8. Be participating in other intervention clinical trials.
9. Judgment by the HCP that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
Primary outcome measure(s)
The proportion of patients who achieve RAASi optimizationa with normal sK+ level (3.5 mmol/L ≤ sK+ ≤5.0 mmol/L) after 48 weeks intervention. — Week 48 To describe the effectiveness of standardized management in patients with CKD and HK for achievement of sK+ control and RAASi optimization
Trial sites (49)
Facility
City
Region
Status
Research Site
Beijing
China
Research Site
Benxi
China
Research Site
Changchun
China
Research Site
Changsha
China
Research Site
Changsha
China
Research Site
Changsha
China
Research Site
Chengdu
China
Research Site
Chengdu
China
Research Site
Chengdu
China
Research Site
Chongqing
China
Research Site
Dalian
China
Research Site
Fuyang
China
Research Site
Fuzhou
China
Research Site
Fuzhou
China
Research Site
Gejiu
China
Research Site
Guangzhou
China
Research Site
Guangzhou
China
Research Site
Guiyang
China
Research Site
Haikou
China
Research Site
Hangzhou
China
Research Site
Hefei
China
Research Site
Hohhot
China
Research Site
Jinan
China
Research Site
Jinan
China
Research Site
Kunming
China
Research Site
Kunming
China
Research Site
Lanzhou
China
Research Site
Nanchang
China
Research Site
Nanning
China
Research Site
Nantong
China
Research Site
Ningbo
China
Research Site
Pingdingshan
China
Research Site
Qiqihar
China
Research Site
Shanghai
China
Research Site
Shanghai
China
Research Site
Shanghai
China
Research Site
Shenyang
China
Research Site
Shijiazhuang
China
Research Site
Taiyuan
China
Research Site
Tianjin
China
+ 9 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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