NCT05814146NARecruiting
Trial of Variable Dialysate Bicarbonate
Brigham and Women's Hospital
Start Date
8/24/2023
Completion Date
10/1/2026
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 Criteria
Age Range: 18 years to 120 years
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
DRUG
Dialysate bicarbonate concentration
DEVICE
Dialysate bicarbonate concentration - telemetry monitoring
Conditions
Peri-dialytic Cardiac RhythmsIntradialytic HypotensionElectrolyte ChangespH ChangesAdverse Symptoms
Locations
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States