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

Primary Purpose

End Stage Renal Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Potassium Removal Maximization

Potassium Gradient Minimization

Alkalosis Avoidance

Acidosis avoidance

Point of Care Testing

Cardiac Monitor

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring arrythmia, hemodialysis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

Duke University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Potassium Removal Maximization Strategy

Potassium Gradient Minimization Strategy

Alkalosis Avoidance Strategy

Acidosis Avoidance Strategy

Arm Description

Dialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia.

Dialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium.

Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis.

Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis.

Outcomes

Primary Outcome Measures

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.

Number of Participants Enrolled Per Month

Assessment of recruitment feasibility.

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.

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.

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.

Secondary Outcome Measures

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).

Mean Duration of Atrial Fibrillation

Incidence of Potentially Lethal Arrhythmias

Potentially lethal arrhythmias defined as asystole, sustained VT, bradycardia for ≥6 seconds.

Number of Screened Patients Who Are Enrolled

Secondary feasibility measure to assess the size of the necessary screening pool.

Incidence of Hospitalization

All-Cause Mortality

Number of participants who die due to any cause.

Cardiovascular Mortality

Number of participants who die due to cardiovascular-related causes.

Full Information

NCT ID

NCT03519347

First Posted

April 26, 2018

Last Updated

July 27, 2023

Sponsor

NYU Langone Health

Collaborators

National Heart, Lung, and Blood Institute (NHLBI), Duke University, National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT03519347

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

November 30, 2018 (Actual)

Primary Completion Date

July 12, 2022 (Actual)

Study Completion Date

October 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

Collaborators

National Heart, Lung, and Blood Institute (NHLBI), Duke University, National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease

Keywords

arrythmia, hemodialysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Potassium Removal Maximization Strategy

Arm Type

Experimental

Arm Description

Dialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia.

Arm Title

Potassium Gradient Minimization Strategy

Arm Type

Experimental

Arm Description

Dialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium.

Arm Title

Alkalosis Avoidance Strategy

Arm Type

Experimental

Arm Description

Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis.

Arm Title

Acidosis Avoidance Strategy

Arm Type

Experimental

Arm Description

Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis.

Intervention Type

Other

Intervention Name(s)

Potassium Removal Maximization

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Potassium Gradient Minimization

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Alkalosis Avoidance

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Acidosis avoidance

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Point of Care Testing

Other Intervention Name(s)

BLUE I-STAT CHEM8+

Intervention Description

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).

Intervention Type

Device

Intervention Name(s)

Cardiac Monitor

Other Intervention Name(s)

LINQ (Medtronic) Implantable Cardiac Loop Recorder (Carelink System)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Adherence With Proposed Interventions

Description

Adherence will be assessed as the percent of sessions in which POC testing is completed and the dialysate is adjusted according to the algorithm.

Time Frame

Up to Week 24

Title

Number of Participants Enrolled Per Month

Description

Assessment of recruitment feasibility.

Time Frame

Up to Week 24

Title

Proportion of Participants Who Experienced Potassium Intervention-Specific Complications

Description

Time Frame

Up to Week 24

Title

Proportion of Participants Who Experience Bicarbonate Intervention-Specific Complications

Description

Time Frame

Up to Week 24

Title

Mean Monthly Duration of Clinically Significant Arrhythmia (CSA)

Description

Time Frame

Up to Week 24

Secondary Outcome Measure Information:

Title

Percent of Sessions in Which POC-Guided Dialysate Prescription Differs From Standard of Care-Guided Prescription

Description

Time Frame

Up to Week 24

Title

Mean Duration of Atrial Fibrillation

Time Frame

Up to Week 24

Title

Incidence of Potentially Lethal Arrhythmias

Description

Potentially lethal arrhythmias defined as asystole, sustained VT, bradycardia for ≥6 seconds.

Time Frame

Up to Week 24

Title

Number of Screened Patients Who Are Enrolled

Description

Secondary feasibility measure to assess the size of the necessary screening pool.

Time Frame

Up to Week 24

Title

Incidence of Hospitalization

Time Frame

Up to Week 24

Title

All-Cause Mortality

Description

Number of participants who die due to any cause.

Time Frame

Up to Week 24

Title

Cardiovascular Mortality

Description

Number of participants who die due to cardiovascular-related causes.

Time Frame

Up to Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Charytan, MD, MSc

Organizational Affiliation

NYU Langone Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University School of Medicine

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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