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Trial of Variable Dialysate Bicarbonate

NCT05814146 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2025-11-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Katherine S Ravi, MD, MPH · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05814146 on ClinicalTrials.gov