NCT05814146

Trial of Variable Dialysate Bicarbonate

Randomized, Controlled, Double-blind Trial of Lower Versus Higher Dialysate Bicarbonate in Hospitalized Maintenance Hemodialysis Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 141 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peri-dialytic Cardiac Rhythms
• Intradialytic Hypotension
• Electrolyte Changes
• pH Changes
• Adverse Symptoms

Interventions

Type	Name	Description
DRUG	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
DEVICE	Dialysate bicarbonate concentration - telemetry monitoring	Patients will be monitored with telemetry on both arms of the trial.

Timeline

• Start date: 2023-08-24
• Primary completion: 2026-09-01
• Completion: 2026-10-01
• First posted: 2023-04-14
• Last updated: 2025-11-24

Locations

1 site across 1 country: United States