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

End Stage Renal Disease Clinical Trial

— RADAR-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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03519347
• Other study ID #: 18-01324
• Secondary ID: R34HL140477-01
• Status: Completed
• Phase: N/A
• Start date: November 30, 2018
• Est. completion date: October 14, 2022

Study information

• Verified date: July 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 14, 2022
• Est. primary completion date: July 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Other:
• Potassium Removal Maximization
This intervention will test whether prioritizing lower potassium dialysate to reduce the incidence of hyperkalemia reduces the incidence of clinically significant arrhythmias compared to an approach minimizing intradialytic fall in serum potassium by using higher potassium dialysates to minimize serum-dialysate potassium gradients. This will be achieved by utilizing an algorithm which couples point-of-care-testing with the choice of one of two dialysate potassium concentrations (2 or 3 mEq/L) that are widely available in dialysis clinics.
• Potassium Gradient Minimization
This intervention will test whether minimizing intradialytic fall in serum potassium by using higher potassium dialysates to minimize serum-dialysate potassium gradients reduces the incidence of clinically significant arrhythmias compared to an approach prioritizing lower potassium dialysate to reduce the incidence of hyperkalemia. This will be achieved by utilizing an algorithm which couples point-of-care-testing with the choice of one of two dialysate potassium concentrations (2 or 3 mEq/L) that are widely available in dialysis clinics.
• Alkalosis Avoidance
The bicarbonate (HCO3) concentration will be adjusted according to the results of point of care testing of serum chemistries and an algorithm prioritizing alkalosis avoidance by use of lower dialysate HCO3 concentrations.
• Acidosis avoidance
The bicarbonate (HCO3) concentration will be adjusted according to the results of point of care testing of serum chemistries and an algorithm prioritizing acidosis avoidance by use of higher dialysate HCO3 concentrations.

Diagnostic Test:
• Point of Care Testing
POC testing will use the Abbott BLUE I-STAT CHEM8+ , a portable, handheld device that provides lab quality analysis within 2-3 minutes using a few drops of whole blood (=100uL).

Device:
• Cardiac Monitor
Device is one-third of the size of a triple-A battery and is placed subcutaneously in the left chest during a brief procedure that can be done in-office under local anesthesia.

Locations

Country	Name	City	State
United States	Duke University School of Medicine	Durham	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
NYU Langone Health	Duke University, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence With Proposed Interventions	Adherence will be assessed as the percent of sessions in which POC testing is completed and the dialysate is adjusted according to the algorithm.	Up to Week 24
Primary	Number of Participants Enrolled Per Month	Assessment of recruitment feasibility.	Up to Week 24
Primary	Proportion of Participants Who Experienced Potassium Intervention-Specific Complications	Potassium Intervention-Specific Complications are defined as either severe potassium abnormalities (potassium = 6.5 or = 3.0 mEq/L) or unscheduled HD or hospitalization for hyper/hypokalemia in the absence of a missed treatment.	Up to Week 24
Primary	Proportion of Participants Who Experience Bicarbonate Intervention-Specific Complications	Bicarbonate Intervention-Specific Complications are defined as severe HCO3 abnormalities (HCO3 <20 or >32 mEq/L) or unscheduled HD or hospitalization for acid base abnormalities in the absence of a missed treatment.	Up to Week 24
Primary	Mean Monthly Duration of Clinically Significant Arrhythmia (CSA)	CSA will be defined on the basis of arrhythmias likely to lead to sudden cardiac arrest (SCA) or serious morbidity and mortality and will include AF, asystole =3 seconds, bradycardia =40 beats per minute lasting =6 seconds, and sustained VT =130 beats per minute lasting =30 seconds.	Up to Week 24
Secondary	Percent of Sessions in Which POC-Guided Dialysate Prescription Differs From Standard of Care-Guided Prescription	The impact of POC testing on trial design will be measured as the percent of sessions in which the POC-guided dialysate prescription differs from a hypothetical prescription in which the choice of dialysate is based solely on the once-monthly lab (usual care).	Up to Week 24
Secondary	Mean Duration of Atrial Fibrillation		Up to Week 24
Secondary	Incidence of Potentially Lethal Arrhythmias	Potentially lethal arrhythmias defined as asystole, sustained VT, bradycardia for =6 seconds.	Up to Week 24
Secondary	Number of Screened Patients Who Are Enrolled	Secondary feasibility measure to assess the size of the necessary screening pool.	Up to Week 24
Secondary	Incidence of Hospitalization		Up to Week 24
Secondary	All-Cause Mortality	Number of participants who die due to any cause.	Up to Week 24
Secondary	Cardiovascular Mortality	Number of participants who die due to cardiovascular-related causes.	Up to Week 24