Trial of Variable Dialysate Bicarbonate

Study Overview
=================
Brief Summary
-----------------
QTc prolongation and premature ventricular contractions (PVCs) are common in hemodialysis (HD) patients and are associated with sudden cardiac death. It is known that higher dialysate bicarbonate is associated with more QTc prolongation during HD sessions. This study aims to assess the effects of lower (30 mEq/L) versus higher (35 mEq/L) dialysate bicarbonate in adult maintenance HD patients admitted to the hospital. The investigators will randomly assign subjects to lower versus higher dialysate bicarbonate concentrations during their hospital stay for up to a maximum of six HD sessions or until their hospital discharge.

Official Title
-----------------
Randomized, Controlled, Double-blind Trial of Lower Versus Higher Dialysate Bicarbonate in Hospitalized Maintenance Hemodialysis Patients

Conditions
-----------------
Peri-dialytic Cardiac Rhythms, Intradialytic Hypotension, Electrolyte Changes, pH Changes, Adverse Symptoms

Intervention / Treatment
-----------------
* Drug: Dialysate bicarbonate concentration
* Device: Dialysate bicarbonate concentration - telemetry monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prevalent end-stage renal disease, on maintenance HD > 90 days age ≥ 18 years old thrice weekly HD Exclusion Criteria: hemoglobin < 8.0 g/dL pregnancy any physical, mental or medical condition which limited the ability to provide written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lower dialysate bicarbonate<br>A lower dialysate bicarbonate will be used in the experimental arm (30 mEq/L). | Drug: Dialysate bicarbonate concentration<br>* Assess how a lower dialysate bicarbonate affects: QTc duration during and between hemodialysis sessions PVC burden during and between hemodialysis sessions Clinically significant arrhythmia during and between hemodialysis sessions Intradialytic hypotension Adverse symptoms during hemodialysis sessions<br>Device: Dialysate bicarbonate concentration - telemetry monitoring<br>* Patients will be monitored with telemetry on both arms of the trial.<br>|
| Active Comparator: Higher dialysate bicarbonate<br>A higher dialysate bicarbonate will be used in the active comparator arm (35 mEq/L). | Drug: Dialysate bicarbonate concentration<br>* Assess how a lower dialysate bicarbonate affects: QTc duration during and between hemodialysis sessions PVC burden during and between hemodialysis sessions Clinically significant arrhythmia during and between hemodialysis sessions Intradialytic hypotension Adverse symptoms during hemodialysis sessions<br>Device: Dialysate bicarbonate concentration - telemetry monitoring<br>* Patients will be monitored with telemetry on both arms of the trial.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTc prolongation | QTc prolongation, calculated as post-HD (just as HD finishing, generally 4 hours from start of HD session) minus pre-HD QTc duration, will be obtained via Holter monitoring. | During hemodialysis procedure (during dialysate administration) |