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NCT Number: NCT06736184

the Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Sodium Zirconium Cyclosilicate (SZC)

Drug

5g/meal*3meals/day

Primary outcomes

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

    Time frame: From enrollment to the end of treatment (totally 12 months)

Study contacts

Contact information is provided by the study sponsor or research team.

zunsong Wang

CONTACT

[email protected]

86+053189269107

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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