About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
prevalent end-stage renal disease, on maintenance HD > 90 days
age ≥ 18 years old
thrice weekly HD
Disqualifiers
hemoglobin < 8.0 g/dL
pregnancy
any physical, mental or medical condition which limited the ability to provide written informed consent
Trial design
Parallel
Treatments tested in this trial
Dialysate bicarbonate concentration
DrugAssess 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
Dialysate bicarbonate concentration - telemetry monitoring
DevicePatients will be monitored with telemetry on both arms of the trial.
Treatment groups
Trial outcomes
Primary outcomes
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.
Other outcomes
PVC frequency
Holter monitors will be used to assess PVC frequency during HD sessions and in the subsequent inter-HD period. The investigators will also assess PVC coupling interval variability in these time intervals.
Clinically significant arrhythmia
As described in the Monitoring in Dialysis (MiD) study, clinically significant arrhythmia is defined as: sustained ventricular tachycardia, bradycardia, asystole and symptomatic arrhythmias.
Intradialytic hypotension
Intradialytic hypotension will be defined as systolic blood pressure \<90 during hemodialysis. The investigators will also conduct sensitivity analyses using alternative definitions of intradialytic hypotension (e.g. nadir intra-hemodialysis systolic blood pressure \<90mmHg if pre-hemodialysis systolic blood pressure is \<160mmHg or nadir intra-hemodialysis systolic blood pressure \<100mmHg if pre-hemodialysis systolic blood pressure is ≥160mmHg). Additionally, the investigators will examine the overall mean decline in systolic blood pressure during hemodialysis as a continuous outcome (intra-hemodialysis systolic blood pressure decline=pre-hemodialysis systolic blood pressure minus nadir systolic blood pressure during hemodialysis).
Electrolytes
Samples are collected from the hemodialysis circuit (no extra blood sticks) for freezing for comprehensive metabolic panels.
Sponsors and contacts
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