Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study A

Completed · Not applicable

Conditions studied: End Stage Renal Disease

In brief

The primary purpose of this study is to test the feasibility of trials which change the dialysate (dialysis bath prescription) of potassium and bicarbonate according to a standardized algorithm and according to the results of blood testing performed prior to each dialysis. In addition, the trial will provide estimates of the extent to which performing dialysis in this way lowers the risk of abnormal heart rhythms in people with kidney failure who are being treated with chronic hemodialysis.

Key facts

Study ID

NCT03519347

Run by

NYU Langone Health

People needed

19

Starts

2018-11-30

Expected to finish

2022-10-14

Last updated by the study team

2023-08-15

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Maintenance hemodialysis therapy for end-stage renal disease
• Age 18-85 years (subjects between 18-40 years old will be required to have at least one of the following: history of congestive failure, diabetes, coronary or peripheral vascular disease, or arrhythmia)
• >30 days since dialysis initiation
• Ability to provide informed consent

You may not qualify if…

• Expected survival <6 monthsRenal transplant, transfer to home or peritoneal dialysis, or to non-study hemodialysis facility anticipated within 6 months
• Prisoners or cognitive disability preventing informed consent
• Pregnancy. A pregnancy test will be required for women of child bearing potential prior to enrollment. A pregnancy test will not be required for women past the age of child-bearing potential >55 years old, women with a history of surgical sterilization, or for women <55 years of age who have not had a menses within the past 12 months.
• Skin condition, immune dysfunction, history of multiple infections or other condition which increases risk of local infection with ILR placement
• Bleeding disorder or anti-coagulation that cannot be reversed for ILR placement
• Existing pacemaker, implantable monitor or defibrillator which precludes device placement
• Chronic, persistent AF. Defined as the presence of persistent AF on all available EKGs at time of recent screening.
• Hemoglobin <8 g/dL-Serum K >6.5 or <3.5 mEq/L within 30 days

Where it is running

• Duke University School of Medicine — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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