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RECRUITING Not applicable ClinicalTrials.gov

Trial of Variable Dialysate Bicarbonate

Sponsor: Brigham and Women's Hospital • ClinicalTrials.gov ID: NCT05814146

Registry updated: 2026-10-13
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Description

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.

Interventions

  • Dialysate bicarbonate concentration (Drug)
    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 (Device)
    Patients will be monitored with telemetry on both arms of the trial.

Eligibility criteria

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

Conditions

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

Locations

  • Brigham and Women's Hospital — Boston, Massachusetts, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record