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

N/ACompletedNCT03519347

NYU Langone Health19 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

End Stage Renal Disease

Interventions

Potassium Removal MaximizationOTHER

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 MinimizationOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke University School of Medicine

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to Week 24

Number of Participants Enrolled Per Month

Assessment of recruitment feasibility.

Time frame: Up to Week 24

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.

Time frame: Up to Week 24

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.

Time frame: Up to Week 24

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.

Time frame: Up to Week 24

Secondary Outcomes

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).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.