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The Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients

NCT ID: NCT06736184

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Disease on Hemodialysis Hypokalemia Hyperkalemia Myocardial Injury

Keywords

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maintenance hemodialysis Potassium Variability Myocardial injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Potassium Variability and Myocardial Injury

Group Type EXPERIMENTAL

Sodium Zirconium Cyclosilicate (SZC)

Intervention Type DRUG

5g/meal\*3meals/day

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sodium Zirconium Cyclosilicate (SZC)

5g/meal\*3meals/day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Complicated with congenital heart disease, myocardial infarction and other heart diseases that may lead to cardiac dysfunction;
2. Combined with other serious diseases, such as immune diseases, severe liver and kidney dysfunction;
3. Unable to cooperate with the researcher due to mental reasons;
4. If the duration of dialysis is less than 4 hours, severe infection;
5. Patients with malignant tumors or major mental disorders;

6, except primary cardiomyopathy;

7\. Severe constipation, intestinal obstruction, etc.

8\. other investigators considered that enrollment was not recommended.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qianfoshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zunsong Wang

Chief of Nephrology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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zunsong Wang

Role: CONTACT

Phone: 86+053189269107

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 28993507 (View on PubMed)

Other Identifiers

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CEIPV-MHD

Identifier Type: -

Identifier Source: org_study_id