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Completed

NCT Number: NCT03519347

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

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.

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Key information

Conditions

End Stage Renal Disease Arrhythmias, Cardiac Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University School of Medicine

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Potassium Removal Maximization

Other

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

Other

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

Other

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

Other

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.

Point of Care Testing

Diagnostic Test

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).

Other names: BLUE I-STAT CHEM8+

Cardiac Monitor

Device

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.

Other names: LINQ (Medtronic) Implantable Cardiac Loop Recorder (Carelink System)

Primary outcomes

  1. Adherence With Proposed Interventions

    Time frame: Up to Week 24

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

  2. Number of Participants Enrolled Per Month

    Time frame: Up to Week 24

    Assessment of recruitment feasibility.

  3. Proportion of Participants Who Experienced Potassium Intervention-Specific Complications

    Time frame: Up to Week 24

    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.

  4. Proportion of Participants Who Experience Bicarbonate Intervention-Specific Complications

    Time frame: Up to Week 24

    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.

  5. Mean Monthly Duration of Clinically Significant Arrhythmia (CSA)

    Time frame: Up to Week 24

    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 outcomes

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

    Time frame: Up to Week 24

    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).

  2. Mean Duration of Atrial Fibrillation

    Time frame: Up to Week 24

  3. Incidence of Potentially Lethal Arrhythmias

    Time frame: Up to Week 24

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

  4. Number of Screened Patients Who Are Enrolled

    Time frame: Up to Week 24

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

  5. Incidence of Hospitalization

    Time frame: Up to Week 24

  6. All-Cause Mortality

    Time frame: Up to Week 24

    Number of participants who die due to any cause.

  7. Cardiovascular Mortality

    Time frame: Up to Week 24

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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

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

Registry information

Official study 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

Acronym: RADAR-A

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 9, 2018
Registry last updated
Aug 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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