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



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 85
Updated:3/14/2019
Start Date:March 4, 2019
End Date:July 1, 2021
Contact:David M Charytan, MD, MSc
Email:dcharytan@bwh.harvard.edu
Phone:617-525-7718

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Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study A (RADAR-A): A Phase 2 Multi-center Study to Evaluate the Safety and Tolerability of Using Point-of-Care-Guided Manipulation of Dialysate Potassium and Dialysate Bicarbonate to Prevent Hemodialysis-Associated Arrhythmias

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.

Within four weeks of consent, subjects will have an Implantable Loop Recorder (ILR)
(Medtronic LINQ) device implanted. Subjects will be given a transmitter/charger and a Patient
Care Assistant which they will be required to keep for the duration of their participation in
the study. ILR tracings will be uploaded automatically and reviewed by the study team for the
occurrence of clinically significant arrhythmia.

Following ILR implantation, subjects will have 1 month of standard dialysis and will
crossover in random order between four month-long periods of dialysis guided by the results
of the point of care testing. Whole blood will be obtained by dialysis staff and immediately
tested on a point of care chemistry analyzer according to the manufacturer's protocol prior
to each dialysis session. The randomized intervention periods will include algorithms that
alter the potassium bath in order to a) maximize potassium removal or b) minimize potassium
removal as well as a second set of algorithms that alter the bicarbonate bath in order to c)
limit acidosis or d) limit alkalosis.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
1
site
Durham, North Carolina 27710
Phone: 919-672-2464
?
mi
from
Durham, NC
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