Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study A
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic; Arrhythmias, Cardiac
Study type: Interventional

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.
    

Intervention name(s): Potassium Removal Maximization; Potassium Gradient Minimization; Alkalosis Avoidance; Acidosis avoidance; Point of Care Testing; Cardiac Monitor
Intervention type(s): Other; Other; Other; Other; Diagnostic Test; Device
Intervention description(s): 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.; 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.; 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.; 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.; 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 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 intervention name(s): BLUE I-STAT CHEM8+; LINQ (Medtronic) Implantable Cardiac Loop Recorder (Carelink System)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: arrythmia; hemodialysis