the Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients

Sponsor
Qianfoshan Hospital
Study ID
NCT06736184
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Chronic Kidney Disease on Hemodialysis
  • Hyperkalemia
  • Hypokalemia
  • Myocardial Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Sodium Zirconium Cyclosilicate (SZC) — DRUG
    5g/meal\*3meals/day

Study Details

The management of serum potassium in maintenance hemodialysis（MHD ）patients is one of the hot topics at present. In order to control hyperkalemia in dialysis patients, the use of hypokalemic dialysate is the most important measure to reduce potassium. This measure effectively reduces serum potassium, but increases the risk of hypokalemia after dialysis, which increases the risk of all-cause death in patients. Hyperkalemia and hypokalemia during and at the end of dialysis are important factors for arrhythmia and death in MHD patients. Due to the intermittent nature of hemodialysis treatment, MHD patients often experience frequent fluctuations in serum potassium, which is a potential risk factor for poor prognosis of MHD patients. Serum potassium variability can better reflect the potassium homeostasis in MHD patients. In addition to hyperkalemia and hypokalemia, serum potassium variability is a potential risk factor affecting the prognosis of MHD patients. At present, there are few studies on the effect of improving serum potassium variability on cardiovascular complications, especially multi-center randomized controlled trials. In this study, sodium zirconium cyclosilicate was used to control hyperkalemia before dialysis and increase potassium concentration in dialysate, so as to reduce the risk of hypokalemia after dialysis, and to verify whether improving serum potassium variability can reduce myocardial injury in hemodialysis patients.

Key Dates

Start date
Mar 1, 2025
Status verified
Dec 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Potassium Variability and Myocardial Injury
  • No Intervention: Control

Primary Outcome Measure

Changes in QTcd at the end of dialysis in different observation groups [ Time Frame: From enrollment to the end of treatment (totally 12 months) ]

Central Contacts

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