跳至主要内容
临床试验/NCT06736184
NCT06736184尚未招募4 期

A Prospective Multicenter Randomized Controlled Trial on the Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients

Qianfoshan Hospital0 个研究点目标入组 100 人开始时间: 2025年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
100
主要终点
Changes in QTcd at the end of dialysis in different observation groups

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-75 years old;
  • Maintenance hemodialysis ≥3 months;
  • Serum potassium ≥5.0mmol/L and ≤8mmol/L before dialysis;
  • Have independent ability;
  • Complete clinical baseline data.

排除标准

  • Complicated with congenital heart disease, myocardial infarction and other heart diseases that may lead to cardiac dysfunction;
  • Combined with other serious diseases, such as immune diseases, severe liver and kidney dysfunction;
  • Unable to cooperate with the researcher due to mental reasons;
  • If the duration of dialysis is less than 4 hours, severe infection;
  • Patients with malignant tumors or major mental disorders;
  • 6, except primary cardiomyopathy;
  • Severe constipation, intestinal obstruction, etc.
  • other investigators considered that enrollment was not recommended.

研究组 & 干预措施

Potassium Variability and Myocardial Injury

Experimental

干预措施: Sodium Zirconium Cyclosilicate (SZC) (Drug)

结局指标

主要结局

Changes in QTcd at the end of dialysis in different observation groups

时间窗: From enrollment to the end of treatment (totally 12 months)

次要结局

未报告次要终点

研究者

发起方
Qianfoshan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zunsong Wang

Chief of Nephrology Department

Qianfoshan Hospital

相似试验