The Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients

NCT06736184 | Not Yet Recruiting Phase 4

• 1 other identifier: CEIPV-MHD
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

maintenance hemodialysis; Potassium Variability; Myocardial injury

Outcome Measures

Primary Outcomes (1)

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

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

Study Arms (2)

Potassium Variability and Myocardial Injury

EXPERIMENTAL

Drug: Sodium Zirconium Cyclosilicate (SZC)

Control

NO INTERVENTION

Interventions

Sodium Zirconium Cyclosilicate (SZC) DRUG

5g/meal\*3meals/day

Potassium Variability and Myocardial Injury

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• , except primary cardiomyopathy;
• \. Severe constipation, intestinal obstruction, etc.
• \. other investigators considered that enrollment was not recommended.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Related Publications (1)

• Pun PH, Middleton JP. Dialysate Potassium, Dialysate Magnesium, and Hemodialysis Risk. J Am Soc Nephrol. 2017 Dec;28(12):3441-3451. doi: 10.1681/ASN.2017060640. Epub 2017 Oct 9.

  PMID: 28993507 BACKGROUND

MeSH Terms

Conditions

Hypokalemia; Hyperkalemia

Interventions

sodium zirconium cyclosilicate

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

zunsong Wang

CONTACT

86+053189269107; wzsong3@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Nephrology Department

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 16, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12