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

NCT06242041 | Unknown Phase 4

• 1 other identifier: 2022CR08
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Potassium Imbalance; Cardiac Arrhythmia; Dialysis; Complications

Keywords

Hyperkalemia; Chronic kidney disease; Maintenance hemodialysis; cardiac electrical stability; New oral potassium-lowering drugs; T wave alternans

Outcome Measures

Primary Outcomes (2)

• Potassium lowering effect

  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.

  To compare the changes of ECG activity between the treatment group and the control group during dialysis after potassium reduction treatment.

  7 weeks.

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

Routine treatment.

Drug: sodium zirconium cyclic silicate

Interventions

sodium zirconium cyclic silicate DRUG

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.

Also known as: hemodialysis

Control group; Treatment group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• poor compliance with dialysis treatment.
• 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.
• 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.
• Severe hematological abnormalities: white blood cells\>20×10\^9/L, platelets≥450×10\^9/L.
• Rhabdomyolysis was diagnosed 4 weeks before screening.
• Taking lactulose, rifaximin or other unabsorbed antibiotics to treat hyperammonemia within 7 days before taking the first medicine.
• Patients cannot take sodium zirconium silicate orally.
• The patient is allergic to sodium zirconium silicate or other components of the drug.
• The life expectancy of patients is less than 1 year.
• Patients during pregnancy and lactation.
• Female patients preparing for pregnancy during the study period.
• Participated in clinical research of other drugs in the month before screening.
• Persons who have lost their autonomous capacity.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University first hospital hemodialysis center

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac; Hyperkalemia; Renal Insufficiency, Chronic

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Central Study Contacts

LI LIU

CONTACT

13601015233; cutewise@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Treatment group: routine treatment, and oral potassium reduction by SZC on non-dialysis day. Control group: routine treatment.

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 5, 2024
• Study Start: February 14, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 5, 2024

Record last verified: 2024-01

Locations

CN (1)