Clinical trial NCT03519347: Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study A
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: arrythmia
hemodialysis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Duke University
name: National Institutes of Health (NIH)
First posted: 2018-05-09
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence With Proposed Interventions
timeFrame: Up to Week 24
measure: Number of Participants Enrolled Per Month
timeFrame: Up to Week 24
measure: Proportion of Participants Who Experienced Potassium Intervention-Specific Complications
timeFrame: Up to Week 24
measure: Proportion of Participants Who Experience Bicarbonate Intervention-Specific Complications
timeFrame: Up to Week 24
measure: Mean Monthly Duration of Clinically Significant Arrhythmia (CSA)
timeFrame: Up to Week 24
Secondary outcomes:
measure: Percent of Sessions in Which POC-Guided Dialysate Prescription Differs From Standard of Care-Guided Prescription
timeFrame: Up to Week 24
measure: Mean Duration of Atrial Fibrillation
timeFrame: Up to Week 24
measure: Incidence of Potentially Lethal Arrhythmias
timeFrame: Up to Week 24
measure: Number of Screened Patients Who Are Enrolled
timeFrame: Up to Week 24
measure: Incidence of Hospitalization
timeFrame: Up to Week 24
measure: All-Cause Mortality
timeFrame: Up to Week 24
measure: Cardiovascular Mortality
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University School of Medicine
state: North Carolina
Study officials:
affiliation: NYU Langone Health
name: David Charytan, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: