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Trial of Variable Dialysate Bicarbonate
Sponsor: 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.
Official title: Randomized, Controlled, Double-blind Trial of Lower Versus Higher Dialysate Bicarbonate in Hospitalized Maintenance Hemodialysis Patients
Key Details
Gender
All
Age Range
18 Years - 120 Years
Study Type
INTERVENTIONAL
Enrollment
141
Start Date
2023-08-24
Completion Date
2026-10-01
Last Updated
2025-11-24
Healthy Volunteers
No
Conditions
Interventions
Dialysate 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
Dialysate bicarbonate concentration - telemetry monitoring
Patients will be monitored with telemetry on both arms of the trial.
Locations (1)
Brigham and Women's Hospital
Boston, Massachusetts, United States