The Effect of Potassium Lowering Drugs on Cardiac Electrical Stability in Hemodialysis Patients (ART Study)

January 28, 2024 updated by: Li LIU, Peking University First Hospital

The Effect of Potassium Lowering Drugs on Cardiac Electrical Stability in Hemodialysis

This study is a multicenter, prospective and randomized controlled study. The experiment includes a 1-week screening period (1 week before dialysis) and a 7-week treatment period (1-4 weeks of dose drip period and 5-7 weeks of evaluation period). During the screening period, all patients were randomly divided into the control group and the treatment group. On the non-dialysis day of the treatment period, the treatment group was given a certain dose of sodium zirconium silicate, and the blood potassium value was measured before and after each dialysis to maintain the blood potassium at 4.0-5.0mmol/L before dialysis. At the same time, 12-lead ECG and 24-hour Holter were completed at the first and last dialysis during the treatment period, and finally the ECG stability and its relationship with blood potassium were evaluated.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Screening period (1 week before administration):

    After 72 hours without dialysis treatment and before dialysis for the first time, complete the set 1 of laboratory inspection group, including hemoglobin, white blood cells, platelets, serum creatinine, urea nitrogen, alanine aminotransferase, aspartate aminotransferase, albumin, potassium, calcium, magnesium and bicarbonate. After dialysis, complete the set 2 of laboratory inspection group, including urea nitrogen and potassium. According to the ratio of 1: 1, the patients were randomly divided into control group (routine treatment) and experimental group (sodium zirconium silicate was given on the basis of routine treatment).

  2. Dose drops period (1st week to 4th week):

Blood samples are collected before and after dialysis for the first time every week to complete the set 3 of laboratory inspection group, including: potassium, and the dosage of SZC is adjusted according to the blood potassium value, which is administered on non-dialysis days, four times a week, starting from 5g/day each time, and the blood potassium before dialysis is maintained at 4.0-5.0mmol/L, which can be adjusted at 10g/week each time, and the highest dosage can be increased to 80g/week.

  1. If the blood potassium is higher than 5.0mmol/L during the follow-up, the amount of SZC can be gradually increased to 30-80g per week.
  2. If during the follow-up, the blood potassium before dialysis is lower than 5mmol/L, and the potassium concentration of dialysate is raised to 3mmol/L, other ion concentrations remain unchanged, including calcium, bicarbonate, sodium and magnesium. If the blood potassium is still below 5mmol/L in the follow-up, the SZC will be reduced to 10g per week. If the blood potassium is lower than 4.0mmol/L in the follow-up, stop the experiment.

In the first week of drip period, 12-lead ECG and Holter were completed on the day of dialysis.

3.Evaluation period (week 5 to week 7): At the end of the experiment, blood was collected before the last dialysis to complete the laboratory inspection group set 1, and the 12-lead electrocardiogram was improved and Holter was worn, while blood was collected after dialysis to complete the laboratory inspection group set 2.

Study Type

Interventional

Enrollment (Estimated)

61

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Peking University first hospital hemodialysis center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age≥18 years old.
  2. ESKD received hemodialysis treatment three times a week for more than 3 months.
  3. After a long interval, before dialysis, the serum potassium was≥5.0mmol/L and was examined for two months in a row.
  4. Screening patients with serum potassium≥5.0mmol/L before dialysis.

Exclusion Criteria:

  1. poor compliance with dialysis treatment.
  2. Acute myocardial infarction, acute coronary syndrome, stroke, epilepsy or thromboembolism (such as deep vein thrombosis or pulmonary embolism, but excluding hemodialysis pathway thrombosis) occurred within 12 weeks before the screening date.
  3. Hypokalemia (blood potassium<3.5mmol/L), hypocalcemia (blood calcium<2.1mmol/L), hypocalcemia (blood magnesium<0.7mmol/L) or severe acidosis (blood bicarbonate<16mmol/L) occurred within 4 weeks before the screening date.
  4. Severe hematological abnormalities: white blood cells>20×10^9/L, platelets≥450×10^9/L.
  5. Rhabdomyolysis was diagnosed 4 weeks before screening.
  6. Taking lactulose, rifaximin or other unabsorbed antibiotics to treat hyperammonemia within 7 days before taking the first medicine.
  7. Patients cannot take sodium zirconium silicate orally.
  8. The patient is allergic to sodium zirconium silicate or other components of the drug.
  9. The life expectancy of patients is less than 1 year.
  10. Patients during pregnancy and lactation.
  11. Female patients preparing for pregnancy during the study period.
  12. Participated in clinical research of other drugs in the month before screening.
  13. Persons who have lost their autonomous capacity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Routine treatment, and on the non-dialysis day, sodium zirconate silicate is given four times a week, starting from 5g/ day each time, and the blood potassium before dialysis is maintained at 4.0-5.0mmol/L, which can be adjusted by 10g/ week each time, and the highest dose can be increased to 80g/ week.
Drug: sodium zirconium cyclic silicate
On the non-dialysis day, the drug was given to patients in the treatment group, four times a week, starting from 5g/day each time, and the blood potassium before dialysis was maintained at 4.0-5.0mmol/L, which could be adjusted at 10g/week each time, and the highest dose could be increased to 80g/ week.
Other Names:
  • hemodialysis
Placebo Comparator: Control group
Routine treatment.
Drug: sodium zirconium cyclic silicate
On the non-dialysis day, the drug was given to patients in the treatment group, four times a week, starting from 5g/day each time, and the blood potassium before dialysis was maintained at 4.0-5.0mmol/L, which could be adjusted at 10g/week each time, and the highest dose could be increased to 80g/ week.
Other Names:
  • hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Potassium lowering effect
Time Frame: 7 weeks.
The decrease of serum potassium in the treatment group before dialysis after using sodium zirconium silicate was compared with that in the control group.
7 weeks.
Changes of ECG stability during dialysis.
Time Frame: 7 weeks.
To compare the changes of ECG activity between the treatment group and the control group during dialysis after potassium reduction treatment.
7 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 28, 2024

First Submitted That Met QC Criteria

January 28, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Actual)

February 5, 2024

Last Update Submitted That Met QC Criteria

January 28, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022CR08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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