Trial of Variable Dialysate Bicarbonate

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-120
SponsorBrigham and Women's Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Dialysate bicarbonate concentration

    Drug

    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

  • Dialysate bicarbonate concentration - telemetry monitoring

    Device

    Patients will be monitored with telemetry on both arms of the trial.

Treatment groups

141 Participants
are divided into 2 treatment groups
Group A: Lower dialysate bicarbonateExperimental treatment 2 interventions
Group B: Higher dialysate bicarbonateActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
During hemodialysis procedure (during dialysate administration)

Secondary outcomes

Other outcomes

1

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.

Time frame
PVCs/hour will be recorded during HD sessions and for ~44-68 hours from the end of the hemodialysis session until the subsequent hemodialysis session.
2

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.

Time frame
Clinically significant arrhythmia will be assessed during hemodialysis sessions and in the subsequent inter-hemodialysis period (until the subsequent hemodialysis session, up to 68 hours).
3

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).

Time frame
Blood pressures will be measured every 15 minutes during HD sessions.
4

Electrolytes

Samples are collected from the hemodialysis circuit (no extra blood sticks) for freezing for comprehensive metabolic panels.

Time frame
Obtained pre- and post-hemodialysis study sessions (just as hemodialysis finishing, generally 4 hours from start of hemodialysis session).

Sponsors and contacts

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