drugset / Trial / NCT05814146

Trial of Variable Dialysate Bicarbonate

NCT05814146

Recruiting 141 enrolled Brigham and Women's Hospital
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2023-08-24
Primary completion
2026-09-01
Completion
2026-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject bicarbonate Small molecule 30 meq
Subject bicarbonate Small molecule 35 meq