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

NYU Langone Health logo

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Withdrawn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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

0 participants in 2 patient groups

Restricted ultrafiltration rate (UFR)
Experimental group
Description:
UFR ≤10 ml/kg/hr
Treatment:
Other: UFR-restricted dialysis
Standard of Care/ Unrestricted UFR
Experimental group
Description:
UFR as needed
Treatment:
Other: UFR-unrestricted dialysis

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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