Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study B (RADAR-B)

NYU Langone Health

Status

Withdrawn

Conditions

End Stage Renal Disease

Treatments

Other: UFR-unrestricted dialysis

Other: UFR-restricted dialysis

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03519360

2017P001737-

R34HL140477-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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)