Randomized, Controlled, Double-blind Trial of Lower Versus Higher Dialysate Bicarbonate in Hospitalized Maintenance Hemodialysis Patients
Brigham and Women's Hospital
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.
Eligibility
- Age range
- 18–120 years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DrugDialysate bicarbonate concentration
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
- DeviceDialysate bicarbonate concentration - telemetry monitoring
Patients will be monitored with telemetry on both arms of the trial.
Location
- Brigham and Women's HospitalBoston, Massachusetts