Trial of Variable Dialysate Bicarbonate

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT05814146
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Aug 24, 2023
Status verified
Nov 2025
Primary completion
Sep 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
141 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lower dialysate bicarbonate
    A lower dialysate bicarbonate will be used in the experimental arm (30 mEq/L).
  • Active Comparator: Higher dialysate bicarbonate
    A higher dialysate bicarbonate will be used in the active comparator arm (35 mEq/L).

Primary Outcome Measure

QTc prolongation [ Time Frame: During hemodialysis procedure (during dialysate administration) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Katherine S Ravi, MD, MPH
617-732-6383

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By research site
Brigham and Women's Hospital· Boston, MA

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