Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study B
Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study B
The purpose of this study is to test the feasibility of trials that change the dialysis
 ultrafiltration rate (UFR) by limiting the maximum rate and to estimate the extent to which
 limiting the ultrafiltration rate reduces 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 alternate between weekly periods in which the
 ultrafiltration rate can be unlimited or in which the ultrafiltration rate is limited to
 ≤10mL/kg/hour.
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

 -  Interdialytic weight gain necessitating an UF rate of ≥13mL/kg/hour of dialysis to
 achieve the target post-dialysis weight in at least half of the dialysis sessions (≥6
 sessions) in the month prior to enrollment

 Exclusion Criteria:

 -  Expected survival <6 months-to allow trial completion

 -  Renal 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)