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RECRUITING
NCT05814146
NA

Trial of Variable Dialysate Bicarbonate

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States