The Effect of Potassium Lowering Drugs on Cardiac Electrical Stability in Hemodialysis

2022CR08

This study is a multicenter, prospective and randomized controlled study. The experiment includes a 1-week screening period (1 week before dialysis) and a 7-week treatment period (1-4 weeks of dose drip period and 5-7 weeks of evaluation period). During the screening period, all patients were randomly divided into the control group and the treatment group. On the non-dialysis day of the treatment period, the treatment group was given a certain dose of sodium zirconium silicate, and the blood potassium value was measured before and after each dialysis to maintain the blood potassium at 4.0-5.0mmol/L before dialysis. At the same time, 12-lead ECG and 24-hour Holter were completed at the first and last dialysis during the treatment period, and finally the ECG stability and its relationship with blood potassium were evaluated.

2022-02-14

2024-12-31

2024-12-31

Recruiting

Early phase I

61

Inclusion Criteria: 1. Age≥18 years old. 2. ESKD received hemodialysis treatment three times a week for more than 3 months. 3. After a long interval, before dialysis, the serum potassium was≥5.0mmol/L and was examined for two months in a row. 4. Screening patients with serum potassium≥5.0mmol/L before dialysis. Exclusion Criteria: 1. poor compliance with dialysis treatment. 2. Acute myocardial infarction, acute coronary syndrome, stroke, epilepsy or thromboembolism (such as deep vein thrombosis or pulmonary embolism, but excluding hemodialysis pathway thrombosis) occurred within 12 weeks before the screening date. 3. Hypokalemia (blood potassium\<3.5mmol/L), hypocalcemia (blood calcium\<2.1mmol/L), hypocalcemia (blood magnesium\<0.7mmol/L) or severe acidosis (blood bicarbonate\<16mmol/L) occurred within 4 weeks before the screening date. 4. Severe hematological abnormalities: white blood cells\>20×10\^9/L, platelets≥450×10\^9/L. 5. Rhabdomyolysis was diagnosed 4 weeks before screening. 6. Taking lactulose, rifaximin or other unabsorbed antibiotics to treat hyperammonemia within 7 days before taking the first medicine. 7. Patients cannot take sodium zirconium silicate orally. 8. The patient is allergic to sodium zirconium silicate or other components of the drug. 9. The life expectancy of patients is less than 1 year. 10. Patients during pregnancy and lactation. 11. Female patients preparing for pregnancy during the study period. 12. Participated in clinical research of other drugs in the month before screening. 13. Persons who have lost their autonomous capacity.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Treatment group: routine treatment, and oral potassium reduction by SZC on non-dialysis day.\n\nControl group: routine treatment.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 61, 'type': 'ESTIMATED'}}

2024-02-05